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Catherine A


A Project Submitted to the Graduate College of Bowling Green State University in partial fulfillment of the requirements for the degree of MASTER OF INDUSTRIAL TECHNOLOGY May 2005 Committee: John W

Chair Donna Trautman Todd C


This project is dedicated to my parents,

Catherine and Stephen Petretich,

for instilling the values of hard work and dedication,

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I would like to extend sincere appreciation to the College of Technology,

for the opportunity to further my education,

with a graduate assistantship in the Department of Technology Systems

The appreciation extends to the graduate college and departmental staff,

especially Kim Strickland and Judy Jennings,

who go above and beyond in keeping customers satisfied

Gratitude is extended to my project committee members,

Trautman and Dr


Thank you for participating on my project committee

Your input and areas of expertise added tremendous value to the project

Your participation was instrumental in fulfilling my degree requirements

Special thanks are entitled to Dr

my committee chair and graduate advisor

I am very grateful to have you not only as a teacher,

You have developed my intellectual abilities and academic background


you have managed to contribute to my growth as a Quality Professional,

by building my confidence and reinforcing my capabilities

Thank you for expanding my knowledge of this “weird stuff”

! Appreciation is extended to the Woodbridge Corporation’s Fremont Plant,

for granting me an internship and eventually fulltime employment

At Woodbridge,

I was able to conduct school projects and experience quality systems in action

My experiences at the Fremont facility were truly valuable and have contributed to my professional development

I would like to thank my current employer,

for encouraging my project topic and allowing me to present,

Thank you for the opportunity to develop new skills,


I am very thankful for my sisters: Debbie,

! I immensely appreciated all of your charitable donations received during my early graduate school days

I especially appreciated your wisdom and encouragement

Thank you for being my sisters and for your love and support

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INTRODUCTION ……………………………………………

Nature of the Problem …………………………………………………

Problem Statement ……………………………………………………

Significance of the Problem ……………………………………………

Objectives ………………………………………………………………

Assumption ……………………………………………………………

Terminology ……………………………………………………………

Endnotes ………………………………………………………………



Process Validation ………………………………………………………

Injection Molding ………


Tools Of The Trade



METHODOLOGY …………………………………………

Problem Restatement ……………………………………………………

Research Design …………………………………………………………

Project Timeline …………………………………………………………





Bibliography ……………………………………………………………


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Nature of the Problem In order to keep a competitive edge,

companies are attempting to expand their core competencies

The core expansion may impact a company’s regulatory umbrella,

since it often involves expansion from industry with minimal regulations to industry with more and stringent regulations

This is most evident in the medical device sector of the healthcare market

Outsourcing part or all of assembly operations is becoming common practice for medical device manufacturers

A June 1999 poll identified that 80% of medical device manufacturers reported outsourcing part of their business,

and 35% expected their outsourcing to increase by more than 10% within their companies in the following two years (Sparrow,

The statistics indicate an upward trend in the medical device market for polymerbased products as is evident with increased alliances between medical device manufacturers and the thermoplastic injection molding industry (Hermanson,

Such alliances can pose challenges to quality systems

The medical device manufacturer is challenged by finding contract manufacturers that can understand and assimilate measures into quality systems that assure compliance with their governing body,

the Food and Drug Administration (FDA)

Changes to the good manufacturing practices (GMPs) in 1996,

put more emphasis on medical device manufacturers to place controls on their component suppliers to assure that the components are safe and effective for use as designed

Since then,

device owners are requiring their suppliers to

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implement GMP-compliant quality systems,

which include process validation (Owens,

In such alliances,

is challenged with meeting expectations of process validation for plastic molding and component assembly processes

In addition,

understanding of and assimilation of the applicable regulations,

such as those instated by the FDA,

must occur in order to be able to communicate with the customer and to meet their needs


not all established quality procedures may be adequate to meet a FDA regulated customer’s requirements

firms want to be able to evidence,

that their device components have been verified or manufactured using validated processes (Owens,

aspiring to become a contract medical device manufacturer,

must review their current infrastructure and quality system to determine changes that must occur in order to achieve compliance to applicable FDA regulations and in turn appeal to medical device manufacturers

One of their biggest undertakings

is comprehension and interpretation of the Quality System Regulation,

The Quality System Regulation is the FDA’s directive for medical device manufacturers

When outsourcing part(s) of the manufacturing process,

the device manufacturer often delegates parts of the code to the contract manufacturer

The most delegated code requirement to the injection molder is section 820

Process Validation

This section of the regulation dictates: “where the results of a process cannot be fully verified by subsequent inspection and test,

the process shall be validated with a high degree of assurance and approved according to established

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This presents the molder with the challenge of how to qualify related equipment,

such as the mold and press as well as the injection process

Although the FDA has published guidelines for process validation,

see Quality Management Systems – Process Validation Guidance,

GHTF/SG3/N99-10:2004 (Edition 2)

Contract molders struggle with creating an efficient and well documented method to achieve validation of the molding process

For this reason,

a procedure that describes how to conduct,

and what data to document to achieve process validation for injection molding,

that is based on FDA guidelines and that would appeal to medical device manufacturers is advocated

Problem Statement The problem of this study is to develop a validation procedure for thermoplastic injection molding processes for the medical device contract manufacturer

Significance of the Problem In the United States,

the overseeing body of medical device manufacturing is the Food and Drug Administration (FDA)

It is a public safety agency,

which was established to correct industry abuses in the early 1900s (Dickinson,

The FDA’s directive for medical device manufacturers is the Quality System Regulation,

Per the regulation,

FDA advocates process validation,

For medical device manufacturers,

the regulation dictates: “where the results of a process cannot be fully verified by subsequent inspection and test,

the process shall be validated with a high degree of assurance and approved according to established procedures” (21CFR 820

manufacturers must be able to demonstrate compliance to this regulation,

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There is no doubt,

For instance,

Vanguard Medical Concepts,

from the FDA for failure to validate a cleaning process with a high degree of assurance per 21 CFR 820

During audits,

FDA is expecting to evidence documented validations

This entails having a validation protocol,

which explains the methods used to validate a process and a report,

which interprets the data collected during validation and concludes if the process has been validated or not

FDA is expecting the device manufacturer to show that their processes are in control

They will be expecting manufacturers to demonstrate that they can maintain control and will be auditing to see how much control they have over their processes (Allen,


the device manufacturer will have high expectations for their suppliers

Demand for process control is becoming evident to contract injection molders

According to the injection molder Unimark’s Joe Pack,

“a lot of customers are telling us: ‘You’re required to have your process in control’

like DeRoyal Plastics Group’s Bill Pittman,

claims process monitoring “is a big selling point for them” (Leventon,

Process validation is the basis for process control

A well orchestrated validation will identify variables that impact the process significantly,

challenge the process by assessing performance at the processing extremes,

and conclude the optimum processing window


it forces a process to be well defined from the aspects of identifying equipment,

and procedures that are required for production

Once a process is defined and the impacting variables are identified,

process control can be achieved


process validation not only ensures compliance to

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but encourages process improvement and ensures consistent high-quality output

It also can reduce costs,

which is good for business (Sahni-Larsen,

of: non-compliance citations to section 820

75 (483s)

Cite molders struggling with qual

impacted by time constraints (time-to-market) …

] Objectives For this project,

four objectives were designed to address the problem

They are as follows: 1

To establish what parts of and related methods for validating an injection molding process

To establish a method for worse-case testing for the injection molding process

To establish a procedure that describes the methods determined in objectives one and two

To establish a template for documenting data collected from performing the procedure,

as established in objective three

Each objective is detailed in terms of its accomplishment in chapter III,

Assumptions The following assumptions were made for the project

The developed procedure applies to prospective process validation

Although the scope of the developed procedure includes validation guidelines for assembly,

the project scope was limited to validation of injection molding processes

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Terminology There are many terms utilized in the medical device and molding industries,

as well as in the process validation discipline

Terms unique to this project are listed below

Footnotes were used to reference the sources,

which can be found at the end of this chapter,

in the section titled “ENDNOTES”

Acceptable Quality Level (AQL)

for the purposes of sampling inspection,

can be considered satisfactory as a process average

⁴ Good Manufacturing Practices (GMP)

today referred to as Quality System Regulation,

² Installation Qualification – Establishing documented evidence that process equipment and ancillary systems have been installed according to the manufacturer’s recommendations and are consistent with the equipment ordered

¹ Operational Qualification – Establishing documented evidence that equipment operates as intended in accordance with pre-established limits and tolerances,

¹ Performance Qualification – Establishing documented evidence that a process is effective and reproducible

¹ Process Validation – Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications

¹ Prospective Validation – Validation conducted prior to the distribution of either a new product,

or product made under a revised manufacturing process,

where the revisions may affect the product’s characteristics

¹ Thermoplastic Injection Molding – A process by which,

the plastic material is melted and then injected into a mold cavity and cooled to a shape that reflects the cavity and core

³ Validation – Confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled

¹ Validation Protocol – A written plan stating how validation will be conducted,

and decision points on what constitutes acceptable test results

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Food and Drug Administration (FDA) – The United States regulatory authority charged with,

granting IND and NDA approvals


¹Medical Device Quality Systems Manual: A Small Entity Compliance Guide http://www

²Quality System Regulation,

Code of Federal Regulations,

?: An Introduction to Plastic Injection Molding and Injection Mold Construction,” (1993-1999): 2-1

⁴American Society For Quality Control,

American National Standard: Sampling Procedures and Tables for Inspection by Attributes,



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REVIEW OF LITERATURE The purpose of this chapter is to examine literature relevant to process validation,

thermoplastic injection molding,

and the tools used to conduct process validation

PROCESS VALIDATION Per the Quality System Regulation,

FDA advocates process validation,

For medical device manufacturers,

the regulation dictates: “where the results of a process cannot be fully verified by subsequent inspection and test,

the process shall be validated with a high degree of assurance and approved according to established procedures” (21CFR 820

medical device manufacturers are requiring their contract manufacturers to be capable of process validation

In addition to the regulatory requirements,

there are many reasons for validating processes

A properly validated process will yield little scrap or rework and result in increased output

Consistent conformance to specifications will result in fewer complaints and recalls

the validation documentation will contain data that can support improvements in the process or the development of the next generation of the process (http://www

Process validation is defined,

as “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications”

According to the FDA’s “Guideline on the General Principles of Process Validation,” it suggests to device manufacturers to include preliminary considerations and five formal elements in a prospective process validation

Prospective validation is a type validation that is conducted prior to the distribution of either a new product,

product made under a revised manufacturing process,

where the revisions may affect the product’s characteristics

These elements are

process performance qualification,

product performance qualification,

and documentation (Weese and Buffaloe,

Before process validation can begin,

there are preliminary activities that must occur

These activities include defining the product to be produced and how it will be produced

This includes defining the product in terms of performance characteristics,

translating the characteristics into specifications,

and considering the product’s end use (Weese and Buffaloe,

Most of these activities are accomplished during product design and confirmed through design validation

In summary,

there must be specifications to validate against

Once the specifications are determined,

Process validation can be broken down into three phases: Installation Qualification (IQ),

Operational Qualification (OQ),

and Performance Qualification (PQ)

Since injection molding is accomplished using equipment,

an installation qualification must be defined for injection molding

The installation qualification creates objective evidence that the equipment to be used in a process is constructed and installed according to the approved design criteria (Schikora,

It establishes by objective evidence that all key aspects of the process and ancillary equipment adhere to the manufacturer’s approved specifications and that the recommendations of the equipment supplier have been considered

Items to consider for the IQ phase are listed in Table I

Some validation activities may be performed at the equipment supplier’s site prior to shipping the equipment


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advantageous to rely solely on the equipment supplier’s validation results

It is ultimately the medical device manufacturer or sub-contractor that is responsible for evaluating,

and testing the equipment and deciding whether the equipment is suitable for use in manufacturing the device (GHTF/SG3/N99-10:2004(Edition 2))


materials of construction cleanability,

) Installation conditions (wiring,

cleaning schedules Safety features Supplier documentation,

and manuals Software documentation Spare parts lists Environmental conditions (such as clean rooms requirements,

humidity) Table I: Installation Qualification Considerations Source: GHTF/SG3/N99-10:2004(Edition 2) The operational qualification serves to test any operational aspects of the installed equipment

In addition,

it also establishes the operating parameters for the process,

in this case- injection molding

The process parameters should be challenged to assure that they will yield a product that meets all defined requirements under all anticipated manufacturing conditions

This challenging is often referred to as “worst case testing”

Items to consider including into the OQ phase are listed in Table II (GHTF/SG3/N9910:2004(Edition 2))


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Process control limits (time,

) Software parameters Raw material specifications Process operating procedures Material handling requirements Process change control Training Short term stability and capability of the process (latitude studies or control charts) Potential failure modes,

and worse-case conditions Use of statistically valid techniques such as screening experiments to establish key process parameters and statistically designed experiments to optimize the process can be used during this phase

Table II: Operational Qualification Considerations Source: GHTF/SG3/N99-10:2004(Edition 2) After the IQ and OQ are completed,

the performance qualification can begin

The performance qualification serves to demonstrate that a process will consistently produce acceptable product under normal operating conditions

Items to consider for the PQ phase are listed in Table III (GHTF/SG3/N99-10:2004(Edition 2))

During the PQ,

validations lots of the product are produced under both normal and worst-case process parameters with normal operators and normal in-process controls (Schikora,

Since most manufacturing procedures permit a number of process parameters to vary within a set operating window,

most manufacturers have difficulty in choosing a reasonable set of extreme operating conditions for the qualification

In addition,

the question of the number of lots or batches that should be made and sampled often arises

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Statistical rationale should be utilized to determine the amount of product to produce during the PQ run

In the absence of statistical rationale,

the common reference of “three batches” is a suggested minimum (Weese and Buffaloe,

PERFORMANCE QUALIFICATION CONSIDERATIONS Actual product and process parameters and procedures established in the OQ Acceptability of the product Assurance of process capability as established in OQ Process repeatability,

long term process stability Table III: Performance Qualification Considerations Source: GHTF/SG3/N99-10:2004(Edition 2)

INJECTION MOLDING As previously stated,

the foundation for achieving validation is an understanding of the process requiring validation

Since the primary objective of this project is to develop a method for validating an injection molding process,

the injection molding process and all related inputs must be understood

Thermoplastic injection molding is defined as a

process by which plastic material is melted and then injected into a mold cavity

Once the melted plastic is in the mold,

it cools to a shape that reflects the mold cavity and core

The form obtained is referred to as the finished part (TECH MOLD INC


Injection Molding Equipment There is equipment specific to injection molding

injection molding is further explained in this section

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The required equipment for

There are several types of injection molding machines or “presses” available with different methods for blending,

and injecting the polymer into the mold

They are available in a range of sizes,

offer choices in clamp tonnage,

depending on the needs of the application (Miller,

Injection molding machines can generally be classified into three categories,

based on machine function: 1) General-purpose machines,

A typical injection molding machine is comprised of the following major components: 1) Injection System,

Figure 1 illustrates the major components (http://www


Figure 1: A single screw injection molding machine for thermoplastics Source: http://www


The following provides a brief description for each of the major injection molding machine components

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Injection System The injection system is comprised of a hopper,

a reciprocating screw and barrel assembly,

Figure 2 illustrates the injection system

This system contains and transports the plastic as it moves through the feeding,

and packing stages (http://www


Figure 2: A singles screw injection molding machine for thermoplastics,

band heaters to heat the barrel,

Source: http://www


As illustrated by Figure 2,

the hopper serves to hold the thermoplastic material that is supplied to molders in the form of small pellets

The pellets are gravity-fed from the hopper into the barrel and screw assembly

The barrel of the injection system supports the reciprocating and plasticizing screw

This screw is used to compress,

The nozzle connects the barrel to the sprue bushing of the mold and creates a seal between the barrel and mold

The nozzle temperature should be set to the material’s melt temperature and the material supplier’s recommendations

Mold System R10 02/21/05

The mold system is comprised of tie bars,

stationary and moving platens,

as well as molding plates that house the cavity,

The mold acts as a heat exchanger,

where the melted thermoplastic solidifies into the shape and dimensions of the cavity

The mold system,

is an assembly of platens and molding plates typically made of steel and shapes the plastic inside the mold cavity,

and ejects the molded part (http://www


Figure 3: A typical three-plate molding system

Source: http://www


Hydraulic System The hydraulic system of an injection molding machine gives the power to open and close the mold,

build and hold the clamping tonnage,

drive the reciprocating screw,

and energize ejector pins and moving mold cores

The hydraulic system is comprised of several components including pumps,

and hydraulic reservoirs (http://www


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Clamping System The clamping system serves to open and close the mold and supports and carries the other mold parts

It also creates force to prevent the mold from opening (http://www


Control System The control system permits consistency and repeatability in machine operation

It monitors and controls the processing parameters,

The process control has a direct impact on the final part quality and the process economics (http://www


This system will be key for validation

Injection Molding Cycle Now that there is a basic understanding of the injection molding equipment,

the injection molding process must be understood

The injection molding cycle can be broken down into four phases: fill,

See Figure 4

The process begins with mixing and melting of resin pellets

The molten polymer moves through the barrel of the machine and is forced,

As the plastic fills and packs the mold,

the part takes the mold’s shape and begins to cool

The molded part is then ejected from the mold and ready for any finishing steps and/or assembly (Miller,

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The Injection Molding Cycle End

Eject Fill Pack Hold Cool/Plastication

Figure 4: The Injection Molding Cycle Source: TECH MOLD INC

? : An Introduction to Plastic Injection Molding and Injection Mold Construction,” (1993-1999): 2-1

Process Parameters Machine selection,

and part design are factors that can impact the injection molding output


there are five specific injection molding processing variables that can have as much or more impact on the process’s success

The variables are: injection velocity,

and cooling temperature and time

Controlling these variables during the injection cycle’s phases,

can help to improve part quality,

and increase overall productivity (Miller,

During phase 1,

the screw advances and plastic flows into the mold

Flow characteristics are determined by melt temperature,

Injection velocity,

the rate at which the screw moves,

is the most critical variable during the fill phase

A polymer flows more easily as injection velocity is increased

If injection velocity is too high,

it can cause excessive shear and result in problems such as splay and

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heat from a higher shear rate can degrade the plastic,

which negatively impacts the properties of the molded part (Miller,

The way plastic flows during fill is also affected by their viscosity,

High viscosity polymers are thick and those with low viscosity are thin and flow more easily

Melt temperature affects viscosity and should be maintained within the supplier’s recommended temperature range (Miller,

Plastic pressure also plays a part during fill,

The melted plastic can be under greater pressure than is indicated by the hydraulic pressure


it is important to understand the flow characteristics of the material being used and to operate the process consistently (Miller,

In phase 2,

the melted plastic is compressed and more material is added to make-up for any shrinking during cooling

Approximately 95% of the material is added during the fill phase and a remaining 5% is added during pack

Plastic pressure is the impacting variable during the pack phase

The screw maintains the pressure for the melt,

which can cause sinks and voids

Cavity pressure variations are the main cause of deviations in plastic parts


it is important to completely fill the mold and to avoid over packing and under packing,

since pack pressure determines part weight and part dimensions

Over packing can result in dimensional problems and difficulty in part ejection

On the other hand,

under packing can result in short shots,

Phase 3,

is impacted by all five process variables stated earlier: injection velocity,

and cooling temperature and time

After the mold is packed,

the plastic remains in the mold until it is partially solidified and the

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A drop in plastic pressure reveals the amount of shrinking that occurs from cooling

This phase can be optimized by decreasing the hold time until the part weight changes

At this time,

the gate is no longer sealed and resin backflows out of the mold

Continuing hold,

which uses more time and energy to produce the part


it is important to maintain pressure on the plastic until the gate freezes (Miller,

Phase 4,

is usually the longest part of the molding cycle,

Substantial gains in productivity can be yielded by optimizing cooling time

Since gates are sealed during this phase,

cooling temperature and time are the only variables at work

The cooling phase can be optimized by balancing the desire to cool rapidly against the quantity of molded-in stress that the final part can withstand (Miller,

& the molding process] TOOLS OF THE TRADE As with most trades,

it is advantageous to have tools that assist with accomplishing the task at hand

The procedure created for this project describes the tools and their use in validating the injection molding process

The following provides background on the tools selected

Master Validation Plan The value of a good planning tool should never be underestimated

or “MVP” as often referred to in the medical device field,

is an essential planning tool for the validation process

The MVP serves to outline all the equipment/processes requiring validation for a given medical device manufacturing R10 02/21/05

Although the MVP can be formatted in many ways,

it usually contains the following (Swain,

1999): •

Project Overview/Scope- A brief discussion of the project’s scope should be included

Equipment Listing- Each piece of equipment included in the scope should be described

Rationale- A brief explanation should be included stating which machines are being validated and which machines are not

Methodology- A brief explanation of the methods and sampling employed should be included

Responsibility Matrix- A listing of tasks with the corresponding team member responsible should be included

General Acceptance Criteria- The acceptance criteria should be briefly stated

Calibration and Testing- A list of auxiliary programs required to support the project

Schedule- A timeline for executing all listed activities may be included

Design of Experiments

By using statistical techniques during process validation,

medical device manufacturers can improve quality,

and increase confidence in results (Buffaloe-Weese,

One of the statistical tools for validation is design of experiments (DOE)

It is helpful in identifying factors requiring control in order for a system or product to pass a ruggedness test (Anderson-Anderson,


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Protocol = written document describing the method (s) utilized and data to be collected Report Report = written document that interprets data collected and concludes if/ if not the process was validated [Insert more info


METHODOLOGY This chapter lists the methods used to develop and to prove regulatory compliance of a procedure for validating an injection molding process,

which was the project’s focus

This chapter begins with a restatement of the problem followed by research design,

documentation template outline,

Problem Restatement The problem for this study is to develop a validation procedure for thermoplastic injection molding processes for the medical device contract manufacturer

Research Design Research was conducted to investigate methods used to validate injection molding processes

As discussed in Chapter 2,

the validation process is typically divided into three phases: Installation Qualification,

Operational Qualification,

The following explains the phases with respect to injection molding

Installation Qualification

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For injection molding,

the installation qualification pertains to verifying that the injection press is installed properly and capable of running the related mold

The installation qualification protocol should describe the necessary test procedures to verify that the press is installed as specified

These qualifications generally include check sheets that describe: testing of emergency stops,

and identification of critical spare parts (Schikora,

The installation qualification protocol template developed for the project will include checks for safety features,

and electrical and supporting utilities

Operational Qualification The operational qualification,

is comprised of three aspects: 1) verification of the injection press operational aspects,

and 3) a four hour capability/mold acceptance run

Figure 5 displays the operational qualification outline

Injection Molding Operational Qualification

• • • • • • • •

Press Operational Aspects Test & Critical Instrument Calibration Verification Control Screens Verification Controls Verification Alarm Verification Reject Mechanism Verification Report Verification Security Verification Training Verification

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E ngineering S tudies Engineering Studies Viscosity Testing Gate Freeze Testing Hold Time Testing Process Characterization

Mold Acceptance Run 4 Hour Capability Run

Figure 5: Injection Molding Operational Qualification As outlined in Figure 5,

the press operational aspects are those key to running the press

Test and critical instruments requiring calibration and used in the molding process must be documented

Control screens verification consists of verifying the press’s control system screen navigation features per the equipment supplier’s documentation

Controls verification verifies that all system controls identified are functioning per the equipment supplier’s documentation and assures parameter settings established for the mold

Alarm verification serves to verify that they function as required

Reject mechanisms,

should be confirmed that they operate as specified

A verification of generating any system reports,

Training verification should be conducted to assure that all appropriate personnel are trained in the applicable manufacturing and inspection procedures

Attachments specific to all of the described press operational aspects will be created and included in the molding protocol template

The procedure’s engineering studies involve the activities during process development

Chapter 2 provides a discussion of the injection molding process

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It identified five specific molding processing variables that can have as much or more impact on the process’s success

The variables were: injection velocity,

and cooling temperature and time

It was also noted that controlling these variables during the injection cycle’s phases,

can help to improve part quality,

and increase overall productivity (Miller,

Based on the processing variables’ potential impact,

the following verifications were incorporated into the validation: Viscosity Testing,

Gate Freeze Testing,

Test results will be summarized into a process data packet


an important aspect to the operational qualification and in achieving validation is challenging the process to determine what happens when conditions arise that cause stress,

These challenges are collectively referred to as “process characterization”

During process characterization,

key process elements are varied and sources of variation having the most impact on the process are determined

One statistical tool proven to determine variability source is Design of Experiments (DOE) (Kim and Kalb,

The Design of Experiment technique is not new to the health-care industry

Medical researchers have long understood the importance of carefully designed experiments

Recent focus by FDA on process validation highlights the need for well-planned experimentation

Such experiments can provide data that will enable device manufacturers to identify the causes of performance variations and to eliminate or reduce such variations by controlling key process parameters,

therefore improving product quality (Kim and Kalb,

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The process characterization included in the procedure will be considered worse-case testing through a 4-corner window study

It is considered to be worse-case testing for both the mold and injection press

This testing,

serves to identify the influence of the equipment on the mold by understanding the effects of the process parameters on critical part dimensions and quality characteristics

This method will challenge the high and low settings with respect to the machine’s process parameters of pressure and temperature

It will challenge the ability of the press and mold to produce a capable part at the extremities,

of pressure and temperature combinations

Figure 6 displays the combinations

Pressure and Temperature Combinations High Temperature / High Pressure High Temperature / Low Pressure Low Temperature / High Pressure Low Temperature / Low Pressure Figure 6: Process Parameter Challenge Combinations The window study will be executed using the information developed and recorded in the process data packet

The press settings will be set at each corner and centerline and run for at least 1 hour

After a 15-minute settle time,

samples will be labeled and collected throughout the runs

Part critical quality characteristics,

as determined by the customer,

will be sampled and evaluated according to ANSI/ASQC Z1

In addition,

there will be an inspection of critical part dimensions,

as determined by the customer and ANSI/ASQC Z1

The acceptance criteria for the window study will employ additional statistical tools,

Statistical Process Control (SPC) charting and process capability (Cpk)

SPC charting,

used since the 1940s for monitoring production results,

provides a visual method for identifying samples that are outside of normal,

With sufficient

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can be calculated to determine how well the process results are centered within a specification range and how well variability is controlled

When results vary greatly,

a greater percentage of the results have the tendency to fall outside the specifications

This means the process is less capable,

resulting in a lower Cpk value (Weese and Buffaloe,

By employing the statistical tools of SPC charting and process capability (Cpk),

the window study acceptance criteria will be as follows: 1) Stability must be demonstrated through control charting for all critical part dimensions

It should be evident that the engineering studies are the key aspect of the operational qualification phase

By executing the described phases,

the result should be a processing window that is well defined for the press and mold requiring validation

These results can then be confirmed through a 4 hour capability study

The capability study is a 4 hour run using the determined “optimum” process parameter settings

After a 15 minute settle time,

one full shot of parts will be collected every 10-minutes totaling 24-shots

Customer specified critical dimension and attribute inspections will be conducted according to the ANSI/ASQC Z1

The acceptance criteria for the run are as follows: 1) All critical dimensions must demonstrate a value of Cpk ≥ 1

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Performance Qualification The performance qualification serves to prove that a process is reproducible and effective

Performance qualifications typically measure results from normal operating conditions (Weese and Buffaloe,

The performance qualification template developed for the project serves to address the reproducibility aspect

It will consist of molding three lots of the desired product within the process parameters established from the operational qualification

The qualification should be carried out to simulate a production run with all operating procedures having been established and with all participants having been trained in the applicable procedures

The protocol will define the lot size

Part sampling for the customer required dimensional and attribute inspections will be conducted according ANSI/ASQC Z1

The acceptance criteria for each lot are as follows: 1) All critical dimensions must demonstrate a value of Cpk ≥ 1

If all three lots meet the acceptance criteria,

the process will be considered validated

Product from a performance qualification can be saleable product provided it meets the acceptance criteria

Procedure Outline Standard operating procedures (SOPs) are essential for any plant’s effectiveness and efficiency

Procedures provide information about how to perform tasks safely,

They describe processes and important steps in the processes,

and help workers remember how to perform tasks

Procedures are also useful in training employees

Figure 7 lists elements of a good procedure (Kieffer,

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The procedure created for this project will establish generalized process validation standards and guidelines for medical classified product for a team oriented organization

It will identify the following: Process Owner,


It will describe the general validation activities from pre-validation to re-validation

It will list related terminology,

with the most attention being placed on the Injection Molding Template

This template will include evaluation criteria and documentation for all three qualification phases: IQ,

PROCEDURE ELEMENTS Describes the purpose of the process or activity

Emphasizes critical steps and does not contain trivia,

or fundamental information that the user is certified as knowing from experience or training

Defines responsibilities

Lists activities sequentially

The core of a good procedure can be a process flow diagram

Gives guidance in case of a problem and clearly defines decision points

Written simply,

At minimum,

Is concise,

The likelihood of reading,

and complying decreases with the number of pages

Is simple and should be written for 6th- to 8th-grade readability

Makes liberal use of visual aids such as flow diagrams,

A chart that is appropriately numbered and controlled could be considered a procedure

Includes forms that ideally are self explanatory

Figure 7: Elements Of A Good Procedure Source: R Kieffer,

“Procedures: Improving Their Quality,” Pharmaceutical Technology (January 2003): 66

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Gap Analysis In order to prove that the procedure developed would meet the provisions for process validation set forth by the Quality System Regulation 21 CFR-Part 820,

a Gap Analysis was created to assess the procedure’s content against the regulation’s section for Process Validation,

Gap Analysis is a technique which permits a comparison of a current situation to a desired state

It is often used to evaluate existing quality systems for compliance to new standards

[Source Further] The gap analysis created served to prove that the procedure developed was adequate to achieve compliance to section 820

of the Quality System Regulation,

This was identified as the desired state in the gap analysis document

See Appendix X,

for the “Process Validation Gap Analysis” that was created to assess the procedure developed for this project

The procedure’s state was assessed by answering a questionnaire,

which was developed from the regulation,

Subpart G- Production and Process Controls,

Section 820

The questionnaire was designed to identify gaps in methods established for process validation


a questionnaire format was selected instead of listing the requirements or guides in statement form

For response to the questionnaire,

three options were provided: Yes,

The “Yes” option was reserved for cases where requirements were met or guides have been incorporated

The “No” option was reserved for cases where requirements were not met,

It also indicated that the related procedural element

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The “N/A” option was reserved for cases where a requirement or guide may not be applicable to the organization’s situation

To support each response,

the questionnaire allotted space for recording evidence,

as to whether or not the requirement was meant

The results of the gap analysis for the procedure can be found in Chapter IV

Project Timeline A Gantt chart was developed to show the time allocated for each of the major project activities

Review of Literature Proposal Development Submit Proposal Develop Procedure Outline Develop Documentatio n Template Prepare Final Drafts Formulate Conclusion and submit project

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2005 Mar


DELIVERABLES and GAP ANALYSIS RESULTS This chapter lists the developed procedure and all related supporting documentation,

as stated in the objectives of Chapter I

In addition,

the results of the Gap Analysis are stated,

which was conducted to prove the procedure’s compliance to the 21CFR Part 820,

Deliverables There were four objectives designed to address the problem

The project objectives were met by creating ten deliverables

Table X lists all the deliverables and a brief description

Each deliverable is further explained in detail below


Validation Procedure- “Validation Practice for Medical Product” 2

Master Validation Plan

Qualification Log

Pre-Validation Checklist 5

Injection Molding IOQ Protocol Template

Description A document providing standards and guidelines for conducting process validation A planning tool which outlines all processes that require validation for a medical device project

It identifies,

and evaluative characteristics to achieve validation A document which tracks all validation protocols,

and master validation plans through numerical listings and descriptions A planning tool which documents a team review of related project aspects to assure that validation activities can begin A document stating the methods to perform,

and the acceptance criteria for conducting installation and operational qualifications R10 02/21/05

for an injection molding process 6

Injection Molding PQ Protocol Template A document stating the methods to perform,

and the acceptance criteria for conducting a performance qualification for an injection molding process 7

Validation Report Template A document summarizing the results and evidencing whether or not the requirements were met for all executed protocols 8

Protocol Addendum Template A document created as part of the corrective action process,

when the validation criteria for an original protocol were not completely satisfied 9

Process Sheet A form used to record injection molding process settings 10

Discrepancy and Deviation Form A form used to document any cases where the approved protocol methods were deviated from or the stated protocol acceptance criteria was not met Table X: Project Deliverables Validation Procedure The primary deliverable was the Validation Procedure,

which can be found in Appendix X

As stated in Chapter III,

the procedure created for the project would establish generalized process validation standards and guidelines for medical classified product,

for a team oriented organization


the procedure was entitled “Validation Practice for Medical Product” and consists of eight pages

The document addresses general procedural aspects,

such as roles and responsibilities,

It identifies a process owner,

the individual who would be responsible for overseeing the procedure

The procedure defines a purpose and scope

It also lists the team members and their responsibilities

Methods for the validation process begin on page two

Pre-validation activities are explained,

along with the use of the “Pre-Validation Checklist”

These activities encourage a team review of the project,

with respect to accomplishing validation

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serves to assure that all supporting items are in place prior to scheduling of an operational qualification

The Qualification Log and the planning tool,

Master Validation Plan (MVP),

followed by an explanation of each validation phase

Page three of the procedure introduces the concept of a validation protocol,

which is defined as a document that describes the validation phase,

and the evaluative characteristics that will be utilized to qualify a process

It also lists the protocol content that should be addressed at each validation phase

The protocol templates for injection molding are mentioned,

The significance of acceptance criteria and data forms are presented,

along with how to obtain protocol approval on page four

Protocol deviations and discrepancies are explained on page five

Page five also addresses validation scheduling and reporting,

including report content and report approvals


the purpose of a validation addendum is provided,

along with reference to the protocol addendum template

Page six of the procedure contains definitions for terms that are unique to the validation topic

This page also provides explanation of re-validation

Page seven contains sections for listing related references,

and suggested individuals for training

Master Validation Plan The master validation plan (MVP) is a planning tool for the validation process

See Appendix X,

for the MVP template developed for use with the procedure

This document,

which should be assigned a control number from the Qualification Log,

is designed to consider all equipment and processes requiring validation for a medical

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It establishes guidelines for employing statistical tools for analyzing data related to accepting and qualifying molded component(s),

assembly equipment and processes

In addition to defining the relationship between quality characteristics,

and acceptable quality levels (AQL),

it states the basis for attribute and variable sampling plans

Besides providing statistical and sampling rationale,

the MVP contains a “Validation Matrix”,

see pages five and six of the plan,

which lists all items to be qualified,

It also tracks the qualification task needing performed,

For all validation tasks identified,

the matrix has a section for documenting the responsible party,

Beginning with page seven of the MVP,

sheets are provided for detailing each qualification in its entirety

The sheets can be customized to account for each item’s unique requirements

For example,

a sample sheet is provided for a molded component

It details each qualification phase,


it lists the key quality characteristics,

along with their acceptance criteria that must be evaluated at each phase

There are also additional qualification outline sheets that are provided for adapting to finishing equipment and purchased components

Qualification Log The purpose of the qualification log is to control all validation protocols and reports,

by documenting an assigned number for each

See Appendix X,

The log is comprised of three sheets,

a sheet for each qualification type

There is a sheet to track all validations,

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The Validation Control Log contains four columns

One column,

documents the number assigned,

along with the “VAL” prefix t