Broad Injectables Page
Plot No. 51-52, Phase-III, Industrial Area, Vill.-Tahliwal, Haroli, Distt.-Una (H.P.) 01 of 01
Mfg. Lic. No.: NNZ/2017/119 & BNZ/2017/120
SETTLE PLATE EXPOSURE REPORT
(BETALACTAM DRY INJECTION PRODUCTION AREA)
Date of Exposure : Test Report No. :
Time of Exposure : Time of Completion :
Date of Incubation : Report Date :
Media Details : Date of Preparation In House Lot No
Soyabean Casien :
Digest Agar
Observation of Incubated Plates
For Fungus For Bacteria
S. Location Grade Incubate at 22.50C +2.50C Incubate at 32.50C +2.50C
No. For 72 hours For 48 hours
cfu/plate cfu/plate
Observation Limit Observation Alert Limit Action Limit
AIR LOCKS & STERILE CORRIDOR
01 Air Lock I Riser D <1 30 50
02 Air Lock II Riser C <1 15 25
03 Garment Cubicle A <1 - -
04 Air Lock III Riser B <1 3 4
05 Sterile Corridor Raiser B <1 3 4
06 Return Air Lock I Raiser B <1 3 4
07 Return Air Lock II Raiser C <1 15 25
BLENDING & DESPENSING ROOM
08 Near Blender (Left) A <1 - -
09 Near Blender (Right) A <1 - -
10 Blending Room Riser B <1 3 4
11 Blending Room Pass Box A <1 - -
RUBBER BUNG UNLOADING ROOM
12 Under LAF (Left) A <1 - -
13 Under LAF (Right) A <1 - -
14 Unloading Room Riser B <1 3 4
FILLING ROOM
15 Riser Near Infeed Table B <1 3 4
16 Riser Near Blending Room Door B <1 3 4
17 Riser Near Sealing Machine B <1 3 4
18 Near Powder Hooper (Left) A <1 - -
19 Near Powder Hooper (Right) A <1 - -
20 Near Stopper Hopper (Left) A <1 - -
21 Near Stopper Hopper (Right) A <1 - -
22 Near Powder Filling A <1 - -
23 Near Sealing Machine B <1 3 4
24 Pass Box A <1 - -
25 Negative Control No
Growth
26 Positive Control Growth
Limits: Area Class A- <1cfu/plate, Class B- <5cfu/plate, Class C- <50cfu/plate, Class D- <100cfu/plate,
Remark: The microbial count of area is Satisfactory/does not Satisfactory as per the above given Limits.
Particulars Analyzed by: Checked By: Approved By:
Name
Signature
Date:
Format No. BI/QM/019/F01-04
