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Cleanroom Validation Results Sampling and Common Dispensing

The document provides validation results from particle count testing performed in the cleanroom areas of Belman Laboratories, Inc. on January 14, 2018. The testing found that sampling, dispensing, sieving, drying, compounding and pulverizing areas met or exceeded the required cleanliness standard of Class 100,000 at 0.5 microns. Specifically, the average particle reading at each test point was below the maximum allowable of 108,960 and 69,060 particles per cubic meter for Class 100,000 cleanrooms. Therefore, the report concludes that the cleanroom areas passed the required cleanliness standard.

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Janple Alzar
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
100% found this document useful (2 votes)
327 views18 pages

Cleanroom Validation Results Sampling and Common Dispensing

The document provides validation results from particle count testing performed in the cleanroom areas of Belman Laboratories, Inc. on January 14, 2018. The testing found that sampling, dispensing, sieving, drying, compounding and pulverizing areas met or exceeded the required cleanliness standard of Class 100,000 at 0.5 microns. Specifically, the average particle reading at each test point was below the maximum allowable of 108,960 and 69,060 particles per cubic meter for Class 100,000 cleanrooms. Therefore, the report concludes that the cleanroom areas passed the required cleanliness standard.

Uploaded by

Janple Alzar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
You are on page 1/ 18

Syscal & Maintenance, Inc.

Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

CLEANROOM
VALIDATION RESULTS
BELMAN LABORATORIES, INC.
Sheridan, Mandaluyong, Metro Manila

SAMPLING, DISPENSING, SIEVING, DRYING,


COMPOUNDING AND PULVERIZING AREA
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

Syscal & Maintenance, Inc.


Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines Tel. No.
(632) 358-0772 / 397-8751 Fax No. (632) 428-1358

CERTIFICATE OF COMPLIANCE
Awarded to

BELMAN LABORATORIES, INC.


Sheridan, Mandaluyong, Metro Manila

This Certifies that Sampling, Dispensing, Sieving, Drying,


Compounding and Pulverizing Area meet or exceed the target of FED STD 209E
Class 100,000 at 0.5 Microns in the rested state.

The following report shows that clean room Passed the required standard of
cleanliness.

Date of Inspection: JANUARY 14, 2018

Certified by:

MR. REDENTOR H. ANTOLIN

PRESIDENT / CEO
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

TABLE OF CONTENTS

CERTIFICATE OF COMPLIANCE. ............................................................................................................................ 2


CLEANROOM INFORMATION.................................................................................................................................... 4
PARTICLE COUNT RESULTS ................................................................................................................................... 5
PARTICLE COUNT PROCEDURES ........................................................................................................................... 6
PARTICLE COUNT TESTING RESULTS (CLEANROOM) ........................................................................................... 7
ROOM PARTICLE COUNT PRINTOUT .................................................................................................................... 8
CLASS 100K CLEANROOM TEST POINTS ............................................................................................................. 19
FILTER LEAK TESTING PROCEDURE ........................................................................................................................ 20
LEAK TESTING RESULTS ........................................................................................................................................ 21
ROOM PRESSURE DIFFERENTIAL ........................................................................................................................... 22
ROOM PRESSURIZATION TEST PROCEDURE .......................................................................................................... 23
ROOM PRESSURIZATION TEST RESULTS ................................................................................................................ 24
VELOCITY TEST RESULT ........................................................................................................................................ 25
AIR VELOCITY TESTING PROCEDURE ..................................................................................................................... 26
HEPA FILTER AIR VELOCITY CHECK TEST RESULTS .................................................................................................. 28
CALIBRATION CERTIFICATES ................................................................................................................................. 31

3
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

CLEANROOM INFORMATION

Date: 14 JANUARY 2018 Report No: SMI04071803

CUSTOMER INFORMATION

Customer: Belman Laboratories, Inc.


Address: Sheridan, Mandaluyong, Metro Manila
Attested by : Lorenzo Grijaldo Department: Engineering

EQUIPMENT INFORMATION

EQUIPMENT: MADE:
Air Particle Counter Kanomax
MODEL: CALIBRATION DATE: May 27, 2017
3905 DUE DATE: May 27, 2018

EQUIPMENT: MADE:
Anemometer Kanomax
MODEL: CALIBRATION April 15, 2017
A533 DATE: DUE DATE: April 15, 2018

4
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

PARTICLE COUNT
RESULTS

5
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

PARTICLE COUNT PROCEDURES

Over all room testing was done with all the equipment in place. The cleanrooms were tested
at work area as per environmental test grid location at 36 inches (0.9m) above the floor. The
rooms were tested at “At Rest” mode.

The following procedures / instruments were used:


1. The APC is purged with a zero-count filter before using to ensure accurate
performance to meet Japanese Industrial Standard B 9921:2010 (JIS).
2. The sampling probe shall be positioned pointing into the airflow. If the direction of
the airflow being sampled is non‐laminar, the inlet of the sampling shall be
directed vertically upward.
3. The APC Data Display Set‐up Screen is set to Cumulative and Differential
Mode at a sample volume of 1 cubic meter.
4. Select the data tagged with particular location names, the location grid pattern is
defined in accordance to FED‐STD‐209 E Cleanroom Standards.
5. The APC unit automatically shows sampling data as well as some key status and
alarm information.
6. Every location grid is tested once, for 1‐minute time interval.
7. All necessary precaution is observed while testing, so as not to disturb the
air flow direction.
8. Samples are automatically stored in its memory and print samples are available
at the end of each

6
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

PARTICLE COUNT TESTING RESULTS


PROJECT : BELMAN LABORATORIES, INC. TEST DATE : Jan. 14, 2019
LOCATION : Mandaluyong City CLEANROOM CLASS : 100,000
AREA : As Shown TEST INSTRUMENT : KANOMAX 3905
CONDITION : At Rest

AVERAGE READING CLASS 100K


AREA TEST POINTS REMARKS
≥0.5µm/ft³ ≥0.5µm/ft³
1 3,520,000 108,960 PASSED
2 3,520,000 69,060 PASSED
SECONDARY 3 3,520,000 63,140 PASSED
GOWNING
4 3,520,000 64,420 PASSED
5 3,520,000 65,460 PASSED
1 3,520,000 297,360 PASSED
ENTRY HALLWAY 2 3,520,000 483,900 PASSED
3 3,520,000 578,460 PASSED
1 352,000 14,480 PASSED
2 352,000 31,380 PASSED
DISPENSING 3 352,000 14,980 PASSED
4 352,000 32,760 PASSED
5 352,000 47,540 PASSED
1 352,000 85,840 PASSED
ANTE ROOM
2 352,000 64,120 PASSED
1 3,520,000 187,900 PASSED
2 3,520,000 195,560 PASSED
WASHING AND
3 3,520,000 243,120 PASSED
EQUIPMENT ROOM
4 3,520,000 240,340 PASSED
5 3,520,000 257,900 PASSED

7
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

AREA AVERAGE READING CLASS 100K


(Continued) TEST POINTS REMARKS
≥0.5µm/ft³ ≥0.5µm/ft³
1 3,520,000 35,800 PASSED
2 3,520,000 41,620 PASSED
HALLWAY 3 3,520,000 26,820 PASSED
4 3,520,000 23,140 PASSED
5 3,520,000 78,300 PASSED
1 352,000 13,680 PASSED
2 352,000 14,000 PASSED
COMPOUNDING 3 352,000 14,960 PASSED
4 352,000 18,600 PASSED
5 352,000 13,380 PASSED
1 3,520,000 137,020 PASSED
DISTILLING 2 3,520,000 146,800 PASSED
3 3,520,000 277,720 PASSED
1 3,520,000 333,680 PASSED
DEGOWNING
2 3,520,000 339,720 PASSED
1 3,520,000 346,740 PASSED
WASH AREA
2 3,520,000 283,660 PASSED
1 3,520,000 152,240 PASSED
GOWNING
2 3,520,000 196,780 PASSED
1 3,520,000 56,860 PASSED
AIRLOCK
2 3,520,000 67,000 PASSED
1 352,000 8,740 PASSED
2 352,000 10,200 PASSED
FILLING AREA 3 352,000 18,740 PASSED
4 352,000 15,380 PASSED
5 352,000 18,200 PASSED
1 3,520,000 133,620 PASSED
RINSING 2 3,520,000 140,220 PASSED
3 3,520,000 101,380 PASSED
1 3,520,000 900,140 PASSED
FINISH PRODUCT
2 3,520,000 1,089,220 PASSED

Prepared By: __________________________ Noted By: ___________________________


Lorenzo Miguel Grijaldo Redentor H. Antolin
Service Engineer Technical Manager

8
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

ROOM PARTICLE COUNT PRINTOUT


(CLEANROOM)

SAMPLING AREA

TEST POINT 1 TEST POINT 2 TEST POINT 3 TEST POINT 4

9
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

DISPENSING AREA
TEST POINT 1 TEST POINT 2 TEST POINT 3

10
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

TEST POINT 4 TEST POINT 5

11
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

SIEVING AREA

TEST POINT 1 TEST POINT 2 TEST POINT 3

12
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

TEST POINT 4 TEST POINT 5

13
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

DRYING AREA

TEST POINT 1 TEST POINT 2 TEST POINT 3 TEST POINT 4

14
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

COMPOUNDING AREA

TEST POINT 1 TEST POINT 2 TEST POINT 3

15
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

TEST POINT 4 TEST POINT 5 TEST POINT 6

16
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

PULVERIZING AREA

TEST POINT 1 TEST POINT 2 TEST POINT 3 TEST POINT 4

17
Syscal & Maintenance, Inc.
Blk 1 Lot 11 Litex Road, Parkwood Hills Subd. Bagong Silangan, 1119 Quezon City, Philippines
Tel. No. (632) 358-0772 / 397-8751 
Fax No. (632) 428-1358

TEST POINT 5 TEST POINT 6 TEST POINT 7 TEST POINT 8

18

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