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Upjohn Suzhou Pharmaceutical Company Limited. VALIDATION FILE NO.UT015 IQ/OQ/PQ VALIDATION PROTOCOL SECTION II --- PROTOCOL COMPRESSED AIR SYSTEM VALIDATION IQ/OQ/PQ PROTOCOL I. OBJECTIVE The purpose of this validation protocol is to verify that the Compressed Air system conformed by Air Compressor Atlas Copco Model ZT 55-8.6, the back up air compressor Comp air K70, dryer, buffer tank and compressed Air loops have been installed according to the installation specifications and perform according to manufacturer's specifications; and the final product compressed air meets URS (QS405.03) II. SYSTEM DESCRIPTION The Compressed Air system consists of two parallel installed air compressor (Master unit and the slave back-up unit), and downstream of the units are air receiver, Dryer, filters, and desiccant dryer installed in serial inside Room 814 of Building #3. Attachment 002. The Compressed Air distribution loop starts from the outlet of the desiccant air dryer, the main pipe supplies Compressed Air to laboratory, production (aseptic and packaging area), warehouse and utilities area, also supplies Compressed Air to Dry Products Area. Normally the master Atlas Copco compressor will be running 24 hours per day except during scheduled maintenance. The slave Air compressor will only run when the master air compressor is down for service. The two Air compressors share the cooling loop via the pipe to outside of wall. The DDC system is monitoring the Compressed air pressure and temperature but does not control the compressed air system. If the air pressure drops the DDC system displays and prints an alarm III. SCOPE Compressed air is supplied by two air compressors System (models Atl55/18 and V200). Model V200 is a standby. They are located in building 3 on the mezzanine. First the air passes through an air drier where excess moisture is removed prior to being distributed throughout the facility via stainless steel (U304 and L316) piping. This protocol addresses the qualification process leading up to final commissioning and approval to use compressed air for all plant requirements, the CA will be distributed to USPCL Dry Products Area (dry products area air loop) aseptic area (sterile products area loop) and QA Labs. For IQ/OQ, tests and checks to be carried out will be a combination of visual checks; drawings revision; functional tests and review of CA system documentation. The work will cover the new Atlas Copco model ZT-55-8-6 pack Screw Air Compressor and the repaired Air Compressor V200; the IQ/OQ will make reference to the original Validation file UT-005. The checks will verify that the installation of both air compressors is as per vendor’s specifications and that all pipes and related equipment has been connected properly as per manufacturer's installation instructions. For PQ (Performance Qualification), testing to be performed for all the use points one time, while for the Fareast use points (S15-R608, S16-R005, S21-R002) will be tested three times with 48 hours interval between each sample. Data produced shall show that compressed air produced is of adequate quality and consistently meet specifications as per updated Quality Standard. | 
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发表于 2012-6-25 14:16:59
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