Equipment Nike 45

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EQUIPMENTEQUIPMENTNike anggraini

0811012045


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INTRODUCTIONINTRODUCTION

y The Good Manufacturing Practices (GMP) regulationrequires that all equipment used to manufacture a

device be designed and installed so that it can beadequately cleaned, serviced, and adjusted asnecessary to maintain the equipment's accuracy,performance, and reliability.

y The degree of maintenance of all equipment and

frequency of calibration of measuring equipment willdepend on the type of equipment, frequency of use,and importance in the manufacturing process.


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MAINTENANCEMAINTENANCE

y Device manufacturers must maintain, clean,

and adjust equipment used in themanufacture of medical devices where failureto do so could have an adverse effect on theequipment's operation and hence the device.

y For example, failure to maintain, clean, andadjust a sealing and/or packaging machineused for primary packaging of sterile deviceswill eventually result in defective packagesand thus nonsterile products.


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adjust equipment, the manufactureradjust equipment, the manufacturermust:must:

have a written schedule for performing theseactivities;

post the schedule or make it readilyavailable;

document the activities; where adjustment is necessary to maintain

proper operation, post the inherent

limitations and allowable tolerances of theequipment or make these readily available topersonnel responsible for making theadjustments; and

audit the activities and document the audit.


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RecordsRecords

y As appropriate, maintenance recordsshould be maintained for each piece ofequipment. Maintenance records andschedules are not needed for equipmentsuch as lathes, presses, grinders, etc.,that are used in a machine shop and

maintained by skilled employ ees on adaily basis. Automated machiningequipment will require maintenanceschedules.


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Equipment SelectionEquipment Selection

y The purchase of stable and accurate measuringequipment can reduce the frequency of

calibration and increase confidence in thecompany's metrology program.y Where economically feasible, equipment with

more accuracy than needed for variousmeasurements can be used longer withoutrecalibration than equipment that marginally

meets the desired accuracy requirements.Delicate instruments, however, that are "pushingthe state-of-the-art" should not be used forroutine measurements unless no other approachis feasible.


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MANUFACTURING MATERIALSMANUFACTURING MATERIALS

y Analyze Usey The use of manufacturing materials that may

adversely affect the finished device should becarefully analyzed. Each process should be designedto use a minimum amount of adverse materials so asto reduce costs, reduce removal efforts, and increasethe in trinsic safety of the device.

y Control Usey

the procedure used for routine cleaning of the deviceand its assemblies can be used for this purpose. If so,a special procedures is not necessary; however, whenresidues from such agents as ethylene oxide must beremoved, special instructions usually are necessary.


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AUTOMATED PRODUCTION ANDAUTOMATED PRODUCTION ANDQA SYSTEMSQA SYSTEMS

y The hardware system, software program and generalquality assurance system controls discussed below areessential in the automated manufacture of medical devices.

The systematic validation of software and associatedequipment will assure compliance with the GMP regulation;and reduce confusion, increase employee morale, reducecosts, and improve quality. Further, proper validation willsmooth the integration of automated production andquality assurance equipment into manufacturingoperations.

y Medical devices and the manufacturing processes used toproduce them vary from the simple to the very complex,thus, the GMP regulation needs to be and is a flexiblequality assurance system. This flexibility is valuable asmore device manufacturers move to automated production,test/inspection, and record-keeping systems.


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Software Validation GuidelinesSoftware Validation Guidelines

y The GMP regulation requires that softwareprograms be validated by adequate and

documented testing when computers are used aspart of an automated production or qualityassurance system. Software used in automatedproduction and quality assuranc e systemsconsists of programs or codes that causecomputerized equipment to perform desired

tasks, plus operator manuals and instructions.y FDA has drafted general guidelines, "Principles

of Process Validation" located in the appendix,that can be used wi th the GMP regulation toestablish a software validation program. Thereare also standards, books, and articles that canbe used for guidance. Military Specification MIL-S-52779A and the Institute of Electrical andElectronic Engineers (IEEE) "Standard fo rSoftware Quality Assurance Plan"


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Formal Development ofFormal Development ofSoftwareSoftware

y The software should be appropriately structuredand documented so that any future changes can

be accomplished, even by a differentprogrammer, with a minimum of difficulty andmaximum reliability.

y To validate software, it must be: structured, documented and evaluated as it is

developed; checked to make sure that it meets

specifications; adequately tested with the assigned hardware

systems; and

operated under varied conditions by theintended operators or

persons of like training to assure that it willperform consistently and correctly.


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Validation of Equipment andValidation of Equipment andProcessesProcesses

y Automated machine tools such as lathes,printed-circuit drills and component inserters

usually can be validated by conducting afirst-and last-piece inspection ofrepresentative product lots. The record ofthis activity may be noted on the routinequality control or production records for the

machine.y Validation of complex microprocessor-

controlled equipment, such as sterilizers, toverify satisfactory operation is generally amore extensive activity than the validation ofmachine tools. Typically, verification must bedone by using a calibrated measurementinstrument to check the actual parametersachieved during trial runs, and comparingthese measurements with the setpoints anddata outputs of the automated system.


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Automated Data Collection andAutomated Data Collection andProcessingProcessing

y In addition to aiding the production of devices,computers may be used to collect and maintain

quality control and production records. Theserecords are called the device history record inthe GMP regulation. A device history is acompilation of records containing the productionhistory of a finished device.

y When device history records or master records

are maintained by computer, appropriate controlsmust be used to assure that data is enteredaccurately, changes are instituted only by authorized personnel, and records are secure. Hardcopy or alternative systems such as duplicates,tapes, or microfilm should also be used to avoidlosing records as a result of inadvertent erasureor other catastrophe. As appropriate, access torecords and data bases should be restricted todesignated individuals.


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EQUIPMENT CALIBRATIONEQUIPMENT CALIBRATION

y The GMP regulation is intended to helpassure that devices will be safe, effective and

in compliance with the FD&C Act. To supportthis goal, each medical device manufacturermust develop and implement a qualityassurance (QA) program that assures with ahigh degree of confidence that all finished

devices meet the company's device masterrecord specifications.y These specifications should, in turn, reflect

the company quality claims (see section501(c), FD&C Act). Such assurance isobtained by many activi ties including themeasurement of component and deviceparameters. These measurements must bemade with appropriate and calibratedequipment.


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y Each manufacturer must assure that

production equipment and qualityassurance measurement equipment(mechanical, electronic, automated, etc.)are:

suitable for the intended use inmanufacture and testing of in-process andfinished devices;

operated by trained employees;

capable of producing valid results; and properly calibrated versus a suitable

standard.


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CALIBRATION REQUIREMENTSCALIBRATION REQUIREMENTS

y The GMP regulation requires that equipment becalibrated according to written procedures that

include specific directions and limits for accuracyand precision

y Precision has no unit of measure and onlyindicates a relative degree of repeatability, i.e.,how closely the values within a series of replicate

measurements agree with each other.Repeatability is the result of resolution andstability.

y Accuracy is the measure of an instrument'scapability to approach a true or absolute value.

Accuracy is a function of precision and bias.Because different manufacturers have differentaccuracy requirements, each manufacturer mustdecide the level of accuracy required for eachmeasurement and provide equipment to achieve

that accuracy.


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GMP calibration requirementsGMP calibration requirementsare:are:

routine calibration according to written procedures; documentation of the calibration of each piece of

equipment requiring calibration; documented validation of the software programs

used in automated production or quality assuranceequipment;

specification of accuracy and precision limits;

training of calibration personnel; use of standards traceable to the National Bureau of

Standards (NBS), or other recognizable standards;and

provisions for remedial action to in-process orfinished devices.

Remedial action includes recalibration andevaluation of the impact of out-of-tolerancemeasurements on the quality of existing in-process orfinished devices, and appropriate corrective action.


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ProceduresProcedures

y A typical calibration procedure includes:

purpose and scope; frequency of calibration;

equipment and standards required;

limits for accuracy and precision;

preliminary examinations andoperations;

calibration process description;

remedial action for product; and

documentation requirements.


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PersonnelPersonnel

y The selection and training of competentcalibration personnel is an important

consideration in establishing an effectivemetrology program. The GMP regulationrequires that, "calibration shall be performedby personnel having the necessary education,training, and experience." Personnel involved

in calibration should ideally possess thefollowing qualities:

y echnical education and experience in the areaof job assignment;

y

basic knowledge of metrology and calibrationconcepts;y an understanding of basic principles of

measurement disciplines,


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y data processing steps, and acceptance

requirements;y ability to follow instructions regarding the

maintenance and use of measurementequipment and standards;

y knowledge of the overall calibrationprogram; and

y mental attitude which results in safe,careful, and exacting execution of his or

her dutie


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RecordsRecords

y Calibration of each piece of equipment

must be documented to include thecalibration date, the calibrator, and thedate the next calibration is due. Manymanufacturers use a system where each

device has a decal or tag which containsthe date of calibration, by whomcalibrated, and date the next calibration isdue. Examples of such decals are shown

on the next page.

y These decals are examples of the typescommonly used to identify the status of

measurement instruments and tools. They


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SchedulesSchedules

y Measuring instruments should be

calibrated at periodic intervals establishedon the basis of stability, purpose, anddegree of usage of the equipment.Intervals should be shortened as required

to assure prescribed accuracy asevidenced by the results of precedingcalibrations. Intervals should belengthened only when the results of

previous calibrations indicate that suchaction will not adversely affect theaccuracy of the system, i.e., the quality ofthe finished product.


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StandardsStandards

y Where practical, the GMP regulation

requires that standards used to calibrateequipment be traceable to the NationalBureau of Standards (NBS), or otherrecognized standards. Traceability also

can be achieved through a contractcalibration laboratory whi ch in turn usesNBS services.


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AUDIT OF CALIBRATIONAUDIT OF CALIBRATIONSYSTEMSYSTEM

y When a medical device manufacturer

utilizes a contract calibration laboratory,FDA expects the manufacturer to haveevidence that the equipment wascalibrated according to the GMP

requirements. The manufacturer can dothis by:

y requiring and receiving certification thatthe equipment was

y calibrated under controlled conditionsusing traceable standards;

y maintaining an adequate calibrationschedule;

y maintaining records of calibration; or


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INTEGRATING MEASUREMENTSINTEGRATING MEASUREMENTSINTO THE QA SYSTEMINTO THE QA SYSTEM

y A good quality assurance program must

include calibration activities. However,proper calibration will be of little useunless the applications of themeasurement equipment are properly

developed and qualified during thepreproduction development of insp ectiontest methods and procedures. As stated,effectiveness depends on the participation

and influence of QA at the preproductionstage.

y Calibration of equipment cannot correctpoor design of products nor can it

compensate for poor applications of


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EXHIBITSEXHIBITS

y Examples of calibration cards, decals, and

cycle cards were presented above in thetext. Examples of a device cleaningprocedure and a calibration procedurefollow. Manufacturers may use these as

presented if they match the firmsoperations; or may modify them to meetspecific requirements.


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P.C. Board CleaningP.C. Board Cleaning

y This procedure covers the cleaning of

printed circuit boards by using anautomatic washer. The procedure coversoperation, shut down, cleaning, androutine maintenance.


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Calibration Procedures forCalibration Procedures forMechanical Measuring ToolsMechanical Measuring Tools

y his is a calibration procedure for

mechanical measuring tools, In actualuse, the initial accuracy of each tool ischecked using the procedure and isrecorded.

y

Thereafter, each tool is recalibrated(checked) versus the initial accuracy. Ofcourse, the initial accuracy must meet orexceed the requirements of the

measurements to be made with the tool.Precision is checked by making severalmeasurements at various points on thetool's measuring face (surface).


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Equipment Nike 45

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