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Qualification Compressed Air SystemHP
Qualification Compressed Air SystemHP
Pharmaceutical - Recommendation
Class ISO 8573 1 : 2001 Compressed Air Quality Standard Solid Particle Water Vapour Oil (incl. Vapour) Maximum number of particle Pressure mg/m per m Dewpoint 0.1 0.5 0.5 1 1 5 0 10 500 1 20 -70 -40 -20 3 7 10 0.01 0.1 1 5 -
Some industry required : Zero class Viable count : < 1 cfu/ft3 Hydrocarbon content : < 0.03 ppm
ISPE Indonesia Affiliate Seminar 8 December 2010
Application ISO 8375 - 1 Maximum number of Class particle per m 0.1 0.5 0.5 1 5 1 100 1 0 100000 100000 100000 1000 1000 1000 10 10 10
Product contact Non Contact Food and food surface contact Non ContactHigh Risk
2.2.1
Systems
To support pharmaceutical production activities, stateof-the-art factories include systems, which have to be conceived according to GEP and cGMP. Some of these systems have a direct impact on product quality, some an indirect impact. Systems with direct impact must be identified and documented in a more exhaustive way, and evaluated in relation to critical GMP parameters. QA, Production and Engineering must agree beforehand on the scope of qualification activities, ideally right at project start.
Impact Assessment
Identify system Develop system Boundaries
Does the system have a Direct impact on product quality No Is the system linked to a Direct impact System? No
YES
YES
No Impact system
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
Indirect Impact :
Raw water treatment Raw water treatment Cooling system Cooling system Effluent treatment Effluent treatment Heating System Heating System Boiler house Boiler house
URS
PQ Test Plan
PQ
FS
OQ
(Incl PDI)
Implementation
IQ
ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities- Volume 5 : Commissioning and Qualification March 2001
URS
Performance Testing
Inc FAT
FS
DS
Inc PDI
Implementation
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
Commissioning
Equipment lists Component lists Utility verification forms System drawings Operating procedures
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
Commissioning
Supplier Responsibility Objective is to identify and rectify problems Approved protocol not required Typically operated by supplier
Validation
User Responsibility Demonstrate process is as specified and under control Must follow an approved protocol Owned & operated by user
Validation
All data & adjustments must be recorded/reviewed Written report is required Reviewed and approved by Quality Assurance
Design Qualification-EDR
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
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10
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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Installation Qualification
Main Unit Verification
Walk through the unit and verify that the installed main component is according to its documentation.
Installation Qualification
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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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.
13
Operational Qualification
OQ check should include: A formal review of all major components in accordance with their intended purpose (PWO-particle,Water,Oil etc). 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.
ISPE Indonesia Affiliate Seminar 8 December 2010
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
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Performance Qualification
WORKSHEET KUALIFIKASI KINERJA
Bagian 1. Kompressor Udara Seharusnya Tekanan Maksimum = 7,0 bar Intercooler Pressure = 2,25 bar Manual dan automatic water drain ; berfungsi / bekerja Tekanan Maksimum= 7,5 bar Manual dan automatic water drain ; berfungsi / bekerja Pendinginan bekerja setelah 15 menit pengoperasian temperatur mendekati 1 C Penyerapan udara lembab berlangsung, udara tekan yang dikeluarkan tidak kurang dari - 40 C Dew Point a. water separatore tidak terjadi kebocoran b. High Efficiency General Purpose Protection tidak bocor dan tidak buntu, dan delta p, pada posisi green maximal 0.35 bar / 5 psi c. High Efficiency Oil Removal Filtration tidak bocor dan tidak buntu, dan delta p, pada posisi green maximal 0.35 bar / 5 psi. d. General Purpose Dust Filtration tidak bocor dan tidak buntu, dan delta p, pada posisi green maximal 0.35 bar / 5 psi . 6. Valve Dapat menyalurkan udara tekan bila dibuka dan terputus bila ditutup, udara tekan tidak ada yang bocor. Hasil Pengamatan Verifikasi
2. Tangki Udara
5. Filter-Filter
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Dew Point
MS ver. 1 - 2010
Particle Count
Pemeriksaan jumlah partikel dilakukan terhadap point of use kritikal dari compressed air, dengan menggunakan particle counter Udara dialirkan melalui flow reducer sebelum diperiksa dengan particle counter. Flow udara tekan diukur menggunakan anemometer sebanyak 6 kali pengukuran, kemudian diambil rataratanya.
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PQ Microbial Measurement
Microbial contamination
Microba dari compressed air ditangkap dengan melewatkannya pada suatu media a.l phosphate buffer pH 7 atau pepton water Mikroba difilter dengan filter steril 0,22 m, filter kemudian diletakkan pada petridish berisi media padat dan dinkubasi pada suhu dan waktu yang sesuai
33
PQ Oil Content
Method : FTIR Gas chromatography Chemical indicator test : used only as initial investigation
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PQ Oil Content
Hydrocarbon
Oli dari compressed air ditangkap dengan cellulose ester filter dengan pore size 0,8 m atau 5,0 m dengan diameter 37 mm Oli pada filter dilarutkan dalam CCl4 Kemudian diperiksa dengan FTIR pada panjang gelombang 2940 cm-1
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PQ Oil Content
1. 2. 3. 4. 5.
Isi impinger dengan calsium chlorida anhydrous Sambung pada titik sampling On kan vacuum Setelah selesai keluarkan Calcium chloride, masukkan kedalam labu pemisah Ekstrak dengan larutan organik dan pisahkan larutan minyaknya menggunakan Rotary Evaporator 6. Ukur dengan GC
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Sampling Principle
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