BIOLIFE MEDICAL (P) LTD.

D 31, SITE IV ,KASNA,GREATER NOIDA UP

Format No.: BL-MC-003-01 C Effective Date: 09.02.2018 Effective Date :08.02.2020

ENVIRONMENTAL MONITORING BY SETTLE PLATE

Date of Exposure : ___________________ Exposed by:____________________

Time of Exposure: From: ________________ To: ___________________

Date & Time of Incubation: In: ___________________ Out:___________________

* (Incubate at 30 -35ºC for 48 hrs and 20-25ºC for 72 hrs)

Sl.No. Room Class Location Alert Limit Action Limit Result Remarks

(CFU/Plate) (CFU/Plate) (CFU/Plate)

1

2
1 Mixing Area 10,000 NMT 25 NMT 50
3

2
2 Filling Area 10,000 NMT 25 NMT 50
3

2
3 Bag Welding Area 10,000 NMT 25 NMT 50
3

2
4 Micro room 1,000 NMT 3 NMT 5
3

2
5 Pouching Area 100,000 NMT 80 NMT 100
3

Positive Control Negetive Control

Name of the Media:_________________ Lot No.:________________ Date Plated:__________

Remarks: ___________________________________________________________________

_____________________________________________________________________________

Performed By:______________________ Reviewed By: _________________

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Date: _____________________________ Date: _______________________

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 B L LIFESCIENCES PVT. LTD.
Corporate Office: A-245, Okhla Industrial Area, Phase-I, New Delhi, India

ENVIRONMENTAL MONITORING BY SETTLE PLATE

Document Ref. No. BL-MC-003-01B Effective Date 08-09-2021

Revision No. 01 Page No. 01 of 02

Date of Exposure : ___________________ Exposed by:____________________

Time of Exposure: From: ________________ To: ___________________

Date & Time of Incubation: In: ___________________ Out:___________________

* (Incubate at 30 -35ºC for 48 hrs and 20-25ºC for 72 hrs)

Sl.No. Room Class Location Alert Limit Action Limit Result Remarks

(CFU/Plate) (CFU/Plate) (CFU/Plate)

1

1 Mixing Area 10,000 3 NMT 25 NMT 50

4

2 Filling Area 10,000 4 NMT 25 NMT 50

5

5
3 Bag Welding Area 10,000 NMT 25 NMT 50
6

10

2
4 Micro room 1,000 NMT 3 NMT 5
3

1
2
3
4
5 Pouching Area 100,000 5 NMT 80 NMT 100

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 5 Pouching Area 100,000 NMT 80 NMT 100
6

1
2
6 Tube Priting Area 10,000 NMT 25 NMT 50
3
4
1
2
7 Tools Storage Area 10,000 NMT 25 NMT 50
3
4
1
2
8 Dispensing booth 10,000 NMT 25 NMT 50
3
4

Positive Control Negetive Control

Name of the Media:_________________ Lot No.:________________ Date Plated:__________

Remarks: ___________________________________________________________________

_____________________________________________________________________________

Performed By:______________________ Reviewed By: _________________

Date: _____________________________ Date: _______________________

Manufacturing Site: Unit-II- D-31, Site IV, UPSIDC Industrial Area Greater Noida, Gautam Buddha Nagar, Uttar Pradesh-(India)-201306

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