equipment nurul

7/30/2019 Equipment Nurul

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NURUL HIDAYAH0811011016

EQUIPMENT


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INTRODUCTION

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

be designed and installed so that it can be adequatelycleaned, serviced, and adjusted as necessary to maintain

the equipment's accuracy, performance, and reliability.

The degree of maintenance of all equipment andfrequency of calibration of measuring equipment willdepend on the type of equipment, frequency of use, andimportance in the manufacturing process.


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MAINTENANCE

Device manufacturers must maintain, clean, andadjust equipment used in the manufacture ofmedical devices where failure to do so could have an

adverse effect on the equipment's operation andhence the device.

For example, failure to maintain, clean, and adjust asealing and/or packaging machine used for primary

packaging of sterile devices will eventually result indefective packages and thus nonsterile products.


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If it is necessary to maintain, clean, or adjustequipment, the manufacturer must:

have a written schedule for performing theseactivities;

post the schedule or make it readily available;

document the activities; where adjustment is necessary to maintain proper

operation, post the inherent limitations andallowable tolerances of the equipment or make these

readily available to personnel responsible for makingthe adjustments; and

audit the activities and document the audit.


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Records

As appropriate, maintenance records should bemaintained for each piece of equipment.Maintenance records and schedules are not neededfor equipment such as lathes, presses, grinders, etc.,that are used in a machine shop and maintained byskilled employ ees on a daily basis. Automatedmachining equipment will require maintenance

schedules.


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Equipment Selection

The purchase of stable and accurate measuringequipment can reduce the frequency of calibration andincrease confidence in the company's metrologyprogram.

Where economically feasible, equipment with moreaccuracy than needed for various measurements can beused longer without recalibration than equipment thatmarginally meets the desired accuracy requirements.

Delicate instruments, however, that are "pushing thestate-of-the-art" should not be used for routinemeasurements unless no other approach is feasible.


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MANUFACTURING MATERIALS

Analyze Use The use of manufacturing materials that may adversely

affect the finished device should be carefully analyzed.Each process should be designed to use a minimumamount of adverse materials so as to reduce costs, reduceremoval efforts, and increase the in trinsic safety of thedevice.

Control Use the procedure used for routine cleaning of the device and

its assemblies can be used for this purpose. If so, aspecial 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 AND QASYSTEMS

The hardware system, software program and general qualityassurance system controls discussed below are essential in theautomated manufacture of medical devices. The systematic

validation of software and associated equipment will assurecompliance with the GMP regulation; and reduce confusion,

increase employee morale, reduce costs, and improve quality.Further, proper validation will smooth the integration ofautomated production and quality assurance equipment intomanufacturing operations.

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 flexible qualityassurance system. This flexibility is valuable as more devicemanufacturers move to automated production,test/inspection, and record-keeping systems.


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Software Validation Guidelines

The GMP regulation requires that software programs bevalidated by adequate and documented testing whencomputers are used as part of an automated production orquality assurance system. Software used in automatedproduction and quality assuranc e systems consists of

programs or codes that cause computerized equipment toperform desired tasks, plus operator manuals andinstructions.

FDA has drafted general guidelines, "Principles of ProcessValidation" located in the appendix, that can be used wi th theGMP regulation to establish a software validation program.

There are also standards, books, and articles that can be usedfor guidance. Military Specification MIL-S-52779A and theInstitute of Electrical and Electronic Engineers (IEEE)"Standard fo r Software Quality Assurance Plan"


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Formal Development of Software

The software should be appropriately structured anddocumented so that any future changes can be accomplished,even by a different programmer, with a minimum of difficultyand maximum reliability.

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 the intended operators

or persons of like training to assure that it will perform

consistently and correctly.


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Validation of Equipment and Processes

Automated machine tools such as lathes, printed-circuitdrills and component inserters usually can be validated

by conducting a first-and last-piece inspection ofrepresentative product lots. The record of this activitymay be noted on the routine quality control or

production records for the machine. Validation of complex microprocessor-controlled

equipment, such as sterilizers, to verify satisfactoryoperation is generally a more extensive activity than the

validation of machine tools. Typically, verification must

be done by using a calibrated measurement instrumentto check the actual parameters achieved during trialruns, and comparing these measurements with thesetpoints and data outputs of the automated system.


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Automated Data Collection and Processing

In addition to aiding the production of devices, computersmay be used to collect and maintain quality control andproduction records. These records are called the devicehistory record in the GMP regulation. A device history is acompilation of records containing the production history of a

finished device. When device history records or master records are

maintained by computer, appropriate controls must be usedto assure that data is entered accurately, changes areinstituted only by author ized personnel, and records aresecure. Hard copy or alternative systems such as duplicates,

tapes, or microfilm should also be used to avoid losing recordsas a result of inadvertent erasure or other catastrophe. Asappropriate, access to records and data bases should berestricted to designated individuals.


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EQUIPMENT CALIBRATION

The GMP regulation is intended to help assure thatdevices will be safe, effective and in compliance with theFD&C Act. To support this goal, each medical devicemanufacturer must develop and implement a qualityassurance (QA) program that assures with a high degree

of confidence that all finished devices meet thecompany's device master record specifications.

These specifications should, in turn, reflect the companyquality claims (see section 501(c), FD&C Act). Suchassurance is obtained by many activi ties including the

measurement of component and device parameters.These measurements must be made with appropriate andcalibrated equipment.


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Each manufacturer must assure that productionequipment and quality assurance measurementequipment (mechanical, electronic, automated, etc.)are:

suitable for the intended use in manufacture andtesting of in-process and finished devices;

operated by trained employees;

capable of producing valid results; and

properly calibrated versus a suitable standard.


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CALIBRATION REQUIREMENTS

The GMP regulation requires that equipment be calibratedaccording to written procedures that include specificdirections and limits for accuracy and precision

Precision has no unit of measure and only indicates a relativedegree of repeatability, i.e., how closely the values within aseries of replicate measurements agree with each other.Repeatability is the result of resolution and stability.

Accuracy is the measure of an instrument's capability toapproach a true or absolute value. Accuracy is a function of

precision and bias. Because different manufacturers havedifferent accuracy requirements, each manufacturer mustdecide the level of accuracy required for each measurementand provide equipment to achieve that accuracy.


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GMP calibration requirements 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 assurance equipment;

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 or finished devices.

Remedial action includes recalibration and evaluation of theimpact of out-of-tolerance measurements on the quality of existingin-process or finished devices, and appropriate corrective action.


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Procedures

A typical calibration procedure includes:

purpose and scope;

frequency of calibration;

equipment and standards required; limits for accuracy and precision;

preliminary examinations and operations;

calibration process description; remedial action for product; and

documentation requirements.


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Personnel

The selection and training of competent calibrationpersonnel is an important consideration in establishingan effective metrology program. The GMP regulationrequires that, "calibration shall be performed bypersonnel having the necessary education, training, and

experience." Personnel involved in calibration shouldideally possess the following qualities:

echnical education and experience in the area of jobassignment;

basic knowledge of metrology and calibration concepts; an understanding of basic principles of measurement

disciplines,


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data processing steps, and acceptance requirements;

ability to follow instructions regarding themaintenance and use of measurement equipment

and standards; knowledge of the overall calibration program; and

mental attitude which results in safe, careful, andexacting execution of his or her dutie


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Records

Calibration of each piece of equipment must bedocumented to include the calibration date, thecalibrator, and the date the next calibration is due.Many manufacturers use a system where each devicehas a decal or tag which contains the date ofcalibration, by whom calibrated, and date the nextcalibration is due. Examples of such decals are

shown on the next page.

These decals are examples of the types commonlyused to identify the status of measurement

instruments and tools. They are available as catalog


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Schedules

Measuring instruments should be calibrated atperiodic intervals established on the basis ofstability, purpose, and degree of usage of theequipment. Intervals should be shortened asrequired to assure prescribed accuracy as evidenced

by the results of preceding calibrations. Intervalsshould be lengthened only when the results of

previous calibrations indicate that such action willnot adversely affect the accuracy of the system, i.e.,the quality of the finished product.


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Standards

Where practical, the GMP regulation requires thatstandards used to calibrate equipment be traceableto the National Bureau of Standards (NBS), or otherrecognized standards. Traceability also can beachieved through a contract calibration laboratory

whi ch in turn uses NBS services.


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EQUIPMENT ENVIRONMENT

As appropriate, environmental controls must beestablished and monitored to assure that measuringinstruments and standards are calibrated and usedin an environment that will not adversely effect theaccuracy required. Consideration should be given tothe effects of temperature, humidity, vibration, andcleanliness when purchasing, using, calibrating, and

storing instruments.


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AUDIT OF CALIBRATION SYSTEM

When a medical device manufacturer utilizes acontract calibration laboratory, FDA expects themanufacturer to have evidence that the equipment

was calibrated according to the GMP requirements.The manufacturer can do this by:

requiring and receiving certification that theequipment was

calibrated under controlled conditions usingtraceable standards;

maintaining an adequate calibration schedule;

maintaining records of calibration; or

eriodicall auditin the contractor to assure

INTEGRATING MEASUREMENTS INTO THE


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INTEGRATING MEASUREMENTS INTO THEQA SYSTEM

A good quality assurance program must includecalibration activities. However, proper calibration

will be of little use unless the applications of themeasurement equipment are properly developed andqualified during the preproduction development ofinsp ection test methods and procedures. As stated,effectiveness depends on the participation andinfluence of QA at the preproduction stage.

Calibration of equipment cannot correct poor designof products nor can it compensate for poorapplications of equipm ent and techniques. It is the

continued use of a completed, integrated quality


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EXHIBITS

Examples of calibration cards, decals, and cyclecards were presented above in the text. Examples ofa device cleaning procedure and a calibrationprocedure follow. Manufacturers may use these aspresented if they match the firms operations; or maymodify them to meet specific requirements.


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P.C. Board Cleaning

This procedure covers the cleaning of printed circuitboards by using an automatic washer. The procedurecovers operation, shut down, cleaning, and routinemaintenance.

Calibration Procedures for Mechanical


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Calibration Procedures for MechanicalMeasuring Tools

his is a calibration procedure for mechanicalmeasuring tools, In actual use, the initial accuracy ofeach tool is checked using the procedure and isrecorded.

Thereafter, each tool is recalibrated (checked) versusthe initial accuracy. Of course, the initial accuracymust meet or exceed the requirements of the

measurements to be made with the tool. Precision ischecked by making several measurements at variouspoints on the tool's measuring face (surface).


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