53771203 qualification compressed air systemhp

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QualificationCompressed Air System

Herny PrasetyaAIM Consultant

ISPE Indonesia Affiliate Seminar 8 December 2010

Pharmaceutical - RecommendationISO 8573 – 1 : 2001 Compressed Air Quality Standard

Solid Particle Water Vapour Oil (incl. Vapour) mg/m³Class Maximum number of particle

per m³Pressure Dewpoint

0.1 – 0.5 µ 0.5 – 1 µ 1 – 5 µ

1 100 1 0 -70 0.012 100 1 10 -40 0.13 - 10 500 -20 14 - - 1 3 55 - - 20 7 -6 - - - 10 -

ISO 8573 – 1 : 2001 Class 1.2.1

Some industry required : •Zero class •Viable count : < 1 cfu/ft3 •Hydrocarbon content : < 0.03 ppm


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How to read :ISO 8573.1 : 2001 Class 1.2.1Equates to :

ISO 8573 - COMPRESSED AIR QUALITY STANDARD


Air Quality Classes

Solid Particle Water Vapour

Oil (incl. Vapour) mg/m³

Application ISO 8375 - 1 Class

Maximum number of particle per m³

Pressure Dewpoint

0.1 – 0.5 µ 0.5 –1 µ

1 – 5 µ

0C

Product contact

1.2.1 100 1 0 -40 0.01

Non Contact 2.4.1 100000 1000 10 3 0.01 Food and food

surface contact

2.2.1 100000 1000 10 -40 0.01

Non Contact-High Risk

2.2.1 100000 1000 10 -40 0.01


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Systems

• To support pharmaceutical production activities, state-of-the-art factories include systems, which have to beconceived according to GEP and cGMP.

• Some of these systems have a direct impact on productquality, some an indirect impact.

• Systems with direct impact must be identified and documented in a more exhaustive way, and evaluatedin relation to critical GMP parameters.

• QA, Production and Engineering must agree beforehandon the scope of qualification activities, ideally right atproject start.


Impact Assessment•Identify system

•Develop system •Boundaries

•Does the system have a•Direct impact on product•quality

•Is the system linked to a•Direct impact System?

•“Indirect Impact”•system

•“Direct Impact”•system

•“ No Impact”•system

•Develop Supporting•rationale

•YES

•YES

•No

•No


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Impact Assessment

• Direct impact:Sistem memberikan dampak langsung pada mutu produk

• Indirect impact :Sistem terkait dengan / pada sistem direct impact

• No impact :Tidak terkait dan tidak berdampak pada mutu produk


IMPACT ASSESSMENT - Direct Impact

• Purified Water• Water For Injection• Clean steam• HVAC• Compressed air, special gases


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Indirect Impact :§ Raw water treatment

§ Cooling system

§ Effluent treatment

§ Heating System

§ Boiler house

§ Raw water treatment

§ Cooling system

§ Effluent treatment

§ Heating System

§ Boiler house


V-MODEL “DIRECT IMPACT” SYSTEM

•URS

•FS

•DS

•Implementation

•IQ

•OQ

•PQ•PQ Test Plan

•OQ Test Plan

•IQ Test Plan

•(Incl FAT)

•(Incl PDI)

•Qualification

•ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities- Volume 5 : Commissioning and Qualification – March 2001

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V-MODEL “INDIRECT IMPACT” SYSTEM

•URS

•FS

•DS

•Implementation

•Physical Completion•& Inspection

•Setting to work•Regulation & Adjustment•Testing

•Performance Testing•Commissioning Plan

•Inc FAT

•Inc PDI

•PDI = Pre Delivery Inspection

•ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities- Volume 5 : Commissioning and Qualification – March 2001

Commissioning Overview

• Takes equipment from installation to operation

• Incorporates a systematic method of testing and documentation

• Proper commissioning tests and documentation satisfy many IQ/OQ requirements


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Commissioning/Validation Documentation Overlap

Commissioning• Equipment lists

• Component lists

• Utility verification forms

• System drawings

• Operating procedures

Validation• Equipment lists

• Component lists

• Utility verification forms

• System drawings

• Operating procedures


Commissioning/Validation Documentation Overlap

Commissioning• Calibration records• Input/output testing

• Loop checks• Alarm testing

• Sequence of operations• Integrated system testing

Validation• Calibration records• Input/output testing

• Loop checks• Alarm testing

• Sequence of operations• Integrated system testing


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Differences Between Commissioning and Validation

Commissioning Validation

• Supplier Responsibility• Objective is to identify and

rectify problems• Approved protocol not required • Typically operated by supplier

• User Responsibility• Demonstrate process is as

specified and under control• Must follow an approved protocol• Owned & operated by user


Differences Between Commissioning and Validation

Commissioning Validation

• Not all data and adjustments are recorded & reviewed

• No written report unless specified• Reviewed for acceptance

by engineering/project team

• All data & adjustments must be recorded/reviewed

• Written report is required• Reviewed and approved by

Quality Assurance


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COMPRESSED AIR SYSTEM QUALIFICATION

• Compressed air system which are in contact with product is a “Direct Impact” system

• Qualification work is needed• OQ/EDR• IQ• OQ• PQ


User Requirement Specification

URS consideration should include :• Quality of air generated from the system

at generation and point of use• Prevention of contamination• Capasity• Safety measure


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Validation Master Plan 1. Introduction2. Purpose of the system3. Scope4. Basic approach to the validation(validation life

cycle) ie:IQ/OQ/PQ,as built drawing5. Responsibilities6. Acceptance Criteria7. Certification and approval8. References


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• Design of the system including material of contruction• Function of each sub-system• Distribution system including welding, receiver and break tank.

Loop vs single pass • Temperature• Expected pressure and flow rate• Initial flushing system to remove all particle, oil and other

contaminant

Design Qualification-EDR


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• The unit are constructed and built in conformity with the specification as specified in the User Requirement Specification

• The unit and all components are installed correctly and the utilities are in line with the equipment requirement

• The unit and all components meet the current GMP requirement and regulatory obligation

• All critical instrument have been identified for calibration• Calibration of the measuring instruments are properly done• Standard Operating Procedures have been identified and listed• Operation manuals required for routine operation and maintenance of

the said system are identified and available• Change control procedure exist and documentation changes system for

the installed state of the equipment are available• Required spare parts are identified

Objective of Installation Qualification


Installation Qualification

• Unit Description• Collect and compile documentation describing the unit provided by

manufacturer. • Verify against actual unit installed and record any discrepancies

• Document Verification• Collect, compile and verify documentation related to the unit including

installation documents, calibration documents and user manuals. Verification is emphasizing in document availability and completion.


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• Main Unit Verification• Walk through the unit and verify that the installed main component is

according to its documentation.

• Utility and Instrument Verification• Walk through the unit and verify that utility for operation of the unit has

been installed properly according to its documentation. • Similar check is applied to instrumentation, probe and measuring device

installed to the unit. • Software and programming installation is verified by compiling

programming documentation and printouts, if any



IQ check the installation and should include :

• Compressor type and capacity• Receiver, dryer and filter capacities• Materials of construction• Correct installation and services supplied• Pressure/leak tests• Pipework has been cleaned or blown clear• Instrument calibration• Preventative maintenance



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Objective of Operational QualificationOperational Qualification is to ensure that unit installed have fulfilled the following criteria:• Unit and all components are operating with given

specification.• All of operation can be carried out by those

component and comply with given condition.


Operational Qualification• Procedure Verification

• Verification of procedure document to be used with the unit.

• Operation Verification• Operation testing of all components of the unit, including the

instrumentation and utilities. All components must be operable at its intended use, at normal condition with specified limit of tolerance.

• Walk through and have all components of the unit, including utilities and instrumentation tested for operability in normal condition according to documentation.

• Record tolerance limit and deviations, if any.


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OQ check should include:• A formal review of all major components in accordance

with their intended purpose (PWO-particle,Water,Oiletc).

• The system is well maintained through an inspection of the components and records of preventive and non routine maintenance as well as deviations.

• All monitoring devices are calibrated and operating as per design.

Operational Qualification


Qualification Outline - PQ

• Document Verification• Verification of complete documentation of the unit, including but

not limited to Installation and Operational Qualification, Standard Operating Procedures of the unit, calibration record of instrument used and related drawing.

• Operational Verification• Verification of operational condition, that the unit and

component are performing as intended and producing the compressed air with predetermined pressure and flow rate.

• Air Quality Verification

• Verification of the air quality produce at discharge point.


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WORKSHEET

KUALIFIKASI KINERJA Bagian Seharusnya Hasil Pengamatan Verifikasi

1. Kompressor Udara Tekanan Maksimum = 7,0 bar

Intercooler Pressure = 2,25 bar

Manual dan automatic water drain ; berfungsi /bekerja

2. Tangki Udara Tekanan Maksimum= 7,5 bar

Manual dan automatic water drain ; berfungsi /bekerja

3. Refrigran Dryer Pendinginan bekerja setelah 15 menitpengoperasian temperatur mendekati 1° C

4. Desiccant Dryer Penyerapan udara lembab berlangsung, udaratekan yang dikeluarkan tidak kurang dari - 40°C Dew Point

5. Filter-Filter a. water separatore tidak terjadi kebocoran

b. High Efficiency General Purpose Protectiontidak bocor dan tidak buntu, dan delta p, padaposisi greenmaximal 0.35 bar / 5 psi

c. High Efficiency Oil Removal Filtration tidakbocor dan tidak buntu, dan delta p, pada posisigreenmaximal 0.35 bar / 5 psi.

d. General Purpose Dust Filtration tidak bocordan tidak buntu, dan delta p, pada posisi greenmaximal 0.35 bar / 5 psi .

6. Valve Dapat menyalurkan udara tekan bila dibukadan terputus bila ditutup, udara tekan tidak adayang bocor.

Performance Qualification


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§ Dew point atau water content, ditentukan§ dengan alat tertentu seperti :

§ Electrolytic hygrometer§ Frost point analysis§ Piezoelectricsorption hygrometer

PQ – Dew Point Measurement


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Dew Point

MS ver. 1 - 2010

Particle Count

• Pemeriksaan jumlah partikel dilakukan terhadappoint of use kritikal dari compressed air, denganmenggunakan particle counter

• Udara dialirkan melalui flow reducer sebelum diperiksa dengan particle counter.

• Flow udara tekan diukur menggunakan anemometer sebanyak 6 kali pengukuran, kemudian diambil rata-ratanya.


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Microbial contaminationØMicroba dari compressed air ditangkap dengan

melewatkannya pada suatu media a.l phosphate buffer pH 7atau pepton waterØMikroba difilter dengan filter steril 0,22 m, filter kemudian

diletakkan pada petridish berisi media padat dan dinkubasipada suhu dan waktu yang sesuai

PQ – Microbial Measurement


PQ – Oil Content

Method :• FTIR• Gas chromatography• Chemical indicator test : used only as

initial investigation


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§ Hydrocarbon§ Oli dari compressed air ditangkap dengan cellulose

ester filter dengan pore size 0,8 m atau 5,0 m dengandiameter 37 mm § Oli pada filter dilarutkan dalam CCl4§ Kemudian diperiksa dengan FTIR pada panjang

gelombang 2940 cm-1

PQ – Oil Content


Oil Vapour Content – ISO 8573-5


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• Extract main zone using carbon disulphite in a shaker for 30 minutes

• Use bemzene, toluene, ethylbenzene and octane as internal standard

• Analyze on gas chromatograph with mass spec detector



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1. Isi impinger dengan calsium chlorida anhydrous2. Sambung pada titik sampling3. On kan vacuum4. Setelah selesai keluarkan Calcium chloride, masukkan kedalam labu pemisah5. Ekstrak dengan larutan organik dan pisahkan larutan minyaknya menggunakan

Rotary Evaporator6. Ukur dengan GC

PQ – Oil Content


Example Testing instrument : multi test


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Sampling Principle

Compressed air

> 160 psiAir impaction sampler

Regulatorreducepsi

Measure flow rate

•Petri Plate•Particle count•Dewpoint•Oil sampler



53771203 qualification compressed air systemhp

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