AHU 2 Performance Qualification

ADVANCED ENZYMES TECHNOLOGIES LTD. A-61/62 MIDC, Malegaon, Sinnar Department: Process Microbiology TITLE : QUALIFICATION RECORD OF AIR HANDLING UNIT 02 (Instrument code AHU 02)

Page 1 of 5 AHU 02 Qualification Reference No. QAL-PMD-024

Supercedes Review Date

Issue date

PERFORMANCE QUALIFICATION This study is carried out to determine that the Air handling Unit, installed in the Process Microbiology Department, performs as intended by repeatedly running the equipment as per the procedure and recording all the relevant information regarding the Air velocities, air changes, particulate count, DOP test and microbiological monitoring of the area. The required instruments and personnel to conduct tests for air velocity, particulate count and DOP tests were provided by M/s. Sunil services. AETL staff witnessed the tests carried out by the staff of the M/s. Sunil services The required instruments for the study are as below 1. Airborne particulate counter. 2. Anemometer 3. Temperature measurement instruments 4. D.O.P photometer The calibration status of the above instruments was checked before start of the performance qualification. The performance qualification included following study 1. DOP tests for all the HEPA filters. 2. Air velocity at the entrance plane of all the HEPA filters. 3. Particle counts at various locations in àt-rest’ condition and sweep (recovery) test of Air lock 03, Media preparation room, Culture storage area, Unloading section & laminar air flow no.03. 4. Check the temperature for the above areas. 5. Microbiological monitoring of the area. 1. DOP test of the HEPA filters The filtration requirement for HEPA (High Efficiency Particulate Air) filters is 99.97% of 0.3 micron particles. The test is carried out using DOP (Di Octytl Phthalate), DOP smoke is generated at one side of the filter and at other side the penetration of the particles is checked. a. Equipment i. An aerosol photometer having a threshold sensitivity of at least 10 micrograms/liter for 0.3 micron particles of Di-Octyl Phthalate (DOP) and a sampling rate of 0.028 M3/min. The instrument use in present study is TDA 2G Aerosol photometer Sr. number 1051 i. A (DOP) generator capable of producing a poly disperse test aerosol when generated with a Laskin nozzle, the approximate light scattering mean droplet size distribution being Over 90% less than 3.0 micron Over 50% less than 0.7 micron Over 10% less than 0.4 micron The calibration status of the equipment checked before start of the test b. Test procedure Direct the test aerosol at the prefilters and scan the HEPA filter matrix and perimeters by passing the probe in overlapping strokes traversing at approx. 3 m/min. c. Acceptance criteria The filters and their installation should show a leak not greater than 0.3 % of the upstream challenge aerosol concentration. d. Results The DOP test was done for all 05 terminal HEPA filters.

PREPARED BY PMD EXECUTIVE

CHECKED BY PMD MANAGER

APPROVED BY QA MANAGER

AUTHORIZED BY FACTORY MANAGER




Issue date

The test results are summarized in the attached test certificates. (See annex I). All the 05 HEPA filters installed in Air lock 03 ,Media preparation room ,Culture storage area ,Unloading section ,Laminar air flow no.03. 2. Air Velocity and air changes test : a. Equipment : A Dwyer make anemometer, was used for the air velocity measurement. b.Test Procedure : Keep the instrument sensor near the filter surface. Take air velocity at five different locations at HEPA filter and arithmetic and record arithmetic mean. Calculation of Number of air changes: Measure the air velocity readings (ft/min) at the supply terminal at five locations and take the average. 6.

1 4

5

2 3

Average air velocity (ft/min) per grill = (1 + 2 + 3 + 4 + 5) / 5 (i.e. total number of readings) Volume of air at each grill (ft3/min) = Air velocity (ft/min) x Grill penetration area (ft2) Grill penetration area = Total grill area – Total area of spacers. (Specer area 65% of filter area) Total volume of air (ft3/min) catered to the room = Volume of air at each grill x No. of grills. No. of air changes per hour = Total Volume of air catered to the room(ft3/min) x 60 Volume of the room (ft3) c. Acceptance criteria Total volume of the air catered by the AHU to different rooms shall not be less than 1400 CFM. The number of air changes in the sterile rooms and change room shall not be less than 20 changes per minute. d. Results Detailed results are presented in Annex II (Test certificate by M/s. Sunil services The volume of air catered by the AHU has been found to be 1468 CFM. The number of air changes at different areas Air lock 03:33.5 Media preparation room: 31.1 Incubation room: 29.2 Unloading section, 30.9 Laminar air flow no.03:.37.5 1. Particle counts at ‘at-rest’ condition and Sweep (Recovery) test for the process microbiology department. a. Equipment : In the present study Met-one make airborne particle counter Moderl 3413 Serial No. 060601132 belonging t to M/s cool tech engineers Mumbai has been used. The calibration status of the instrument has been checked before starting the study. b. Test Procedure i. Particulate counting : The particle count is carried out at ‘at-rest’ facility. Definitions Àt-rest process microbiology department. (Facility): process microbiology department (facility) that is complete with all the services functioning and with equipment installed and operable or operating, as specified, but without operating personnel in the facility.








Issue date The particle count is carried out for each filter near the terminal air filter and at 3’ to 4” at ground level just underneath the filter. The arithmetic mean of the particle count at different locations in a room is considered as the particle count of that room. B. Sweep (Recovery) test for process microbiology department : This test is conducted to check the time required for the recovery of a contaminated area to class 100000. Leave the area under consideration is left without protection. During this time the AHU is kept OFF and all the doors are left open. Keep the instrument in the rooms under test. Start the particle count and Air handling unit simultaneously. 7. Note the time required to achieve particle count less than 4338&5682,8620&3434,6074&6660,4009,6669,4902&,8693, particles/ft 3 of 0.5 micron and less than 276&266,417&204,323&379,279&373,302&411 of 830 particles /ft 3 of 5 micron. of incubator rom ,Laminar air flow no.03. Unloading section, Media preparation room, laminar air flow no.03 respectively. Acceptance criteria Particle count in the area The particle count in the area at àt-rest’ condition shall be less than 99,773 particles of 0.5 micron per cubic feet and 830 particles of 5.0 micron per cubic feet. The above requirements satisfy the class 100000 requirements of Federal Standard 209. Sweep (Recovery) test The particle count less than 99773/ ft 3 of 0.5 micron and 830 particles/ ft 3 of 5.0 micron must be achieved within 10 minutes of AHU operation. Results Particle count in the area The data presented in Annex III is the summary of the findings of particle count test at various clean zones. In all the cases the count was • Less than 99773 particles per cubic feet of 0.5 micron particles. • Less than 830 particles per cubic feet of 5 micron. Sweep (Recovery) test Laminar air flow no.03:.attained particle count less than 100000/ft 3 (0.5 micron) in six minutes. Initial count (0 min)

: 0.5 micron particles – 123339/ft3 5.0 micron particles – 52040 /ft3 After 1 minute : 0.5 micron particles 69640/ft3 5.0 micron particles – 20658/ft3 After 2 minute : 0.5 micron particles 35511/ft3 5.0 micron particles – 5575/ft3 After 3 minute : 0.5 micron particles 26372/ft3 5.0 micron particles – 4493/ft3 After 4 minute : 0.5 micron particles 5543/ft3 5.0 micron particles – 1541/ft3 After 5 minute : 0.5 micron particles 3397/ft3 5.0 micron particles – 684/ft3 After 6 minute : 0.5 micron particles 1689/ft3 5.0 micron particles – 431/ft3 In above case, particle count (1689 particle/ft3) of 0.5 micron and 431 particles/ft3 of 5.0 micron) was achieved well before 10 minutes.








Issue date The particle count in the area and recovery test results met the acceptance criteria and conform the US federal standard ISO 14644 for class 100000. The detailed results, instrument printouts are appended as annex. IV. 4. Temperature check for the area Equipment: Maximum temperature: Minimum temperature : The above results satisfy the acceptance criteria for temperature the process microbiology department. Microbiological monitoring of the process microbiology department . a. Equipment: 90 mm Petri dishes were used for the `settle-plate’ study and 55 mm plates were used for `contact-plate’ study. b. Test procedure: Two growth media were used in the study. The media details are given below Sr No

Growth medium

Lot No.

Expiry

1

Growth promotion test status OK

Date of medium preparation 24.06.11

Date of exposure

Results recorded on 28.06.11

Soyabean casein 000002603 NOV 26.06.11 digest agar 9 2012 2 Sabround’s 000002248 SEP2011 OK 24.06.11 26.06.11 01.07.11 chloramphenicol 9 agar Preparation of the media plates for exposure: SOP-PMD-025 followed to prepare the plates for exposure. c. Two procedures were used to study the microbial load in the area : i. Settle plate: For settle plate study the plates were exposed for 4 hours in the Process Microbiology department with the Air-handling unit in ÒN’ condition. ii. Contact Plate: The media surface was touched (contacted) at the clean room area surface at various locations and incubated to observe the microbial growth. The plates were exposed/contacted at the following locations 8. Air lock 03, Media preparation room, Culture storage area, Unloading section, Laminar air flow no.03. Sr no Location Remarks 1. Air lock 03 Both media plates exposed 2. Media preparation room Both media plates exposed 3. Culture storage area Both media plates exposed 4. Unloading section Both media plates exposed 5. ,Laminar air flow no.03. Both media plates exposed After exposure, the Soya-bean casein agar media plates were incubated at 37 +1°C for 48 hours and Saboraud’s plates at 30+1°C for 120 hours. Also one unexposed plate of both the media was incubated, these unexposed plates served as negative control. After incubation the number of appeared colony forming unit were counted and results were recorded. Acceptance criteria: Appearance of not more than 100 colony forming unit on any of the settle-plates after four exposure in the above room and appearance of not more than 50 colony forming units on any of the contact plates. d. Results : The maximum counts recorded in the corridor area, the counts were Settle plate Sabroud’s Chloramphenicol agar 12








Issue date Soyabean casein digest agar 33 Sabroud’s Chloramphenicol agar 08 Soyabean casein digest agar 21 The detailed results are presented in the table appended as Annex. Results obtained in the present study meet the acceptance criteria. Contact plate





AHU 2 Performance Qualification

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