Bl-SOP-067 Environmental SOP

B L LIFESCIENCES PVT. LTD.
28-D, Sector-31, Ecotech-I, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh-(India)
Standard Operating Procedure

Title Environmental Monitoring of Clean Room Effective Date 01-07-2022
Document No. BL/SOP/067 Review Date 30-06-2024
Revision No. 01 Page No. 1 of 5
Objective
To Monitor the environmental conditions in which product is being manufactured to
safeguard the Quality of the product.
1. Scope
This procedure is applicable to all clean rooms area of B L Lifesciences Pvt. Ltd., Unit-I &
Unit-II.
2. Responsibility
The Q.A. Department is responsible for environment monitoring of clean room.
3. Procedure
The following methods are employed to monitor the environment of clean room.
4.1 Particulate cleanliness of clean room and clean room classification
4.1.1 Reference.
4.1.1.1 14644
4.1.1.2 Drugs & Cosmetics Act.1940 (Schedule M).
4.1.1.3 Clean Room is classified as class 10,000 at rest condition and
class 100000 at operation condition. The limits of particle count
and the number of locations for sampling in each section are as
follows (Reference: Drug & Cosmetic Act 2010 (Schedule M))
and (Reference: Table 1 of ISO 14644-1):
4.1.1.4 Environmental Conditions. The following environmental
conditions to be maintained in clean room refer to table I and
controlled rooms.
Sr. No. Parameters Requirements Schedule
01 Temperature 20- 26°C Thrice a day
02 Humidity 40- 60%
Pressure in Std. Alert Action Limit Schedule
Dispensing Value Limit
Room (Pascal)
01 Dispensing
20 18 Less than 18
Room
02 White Zone 35 33 Less than 33
03 Gray Zone 20 18 Less than 18
04 All Pass
Boxes/ Dress Thrice a day
5 3 Less than 3
cabinet (mm
of water)
05 Particulate Six monthly
352000Of 0.5µ and 2930 of 5µ.
matter in air (external agency)
06 HEPA No leakage Yearly (external
Name Designation Signature Date
Prepared by Munjraj Singh AM QC 01-07-2022
Reviewed by Priyanka Sachan Manager QA 01-07-2022
Approved by Hemant Singh GM Operations 01-07-2022


Integrity test agency)

07 No of Air Six monthly
NLT 20
Change rate (external agency)
08 Microbial. At least
Max 50cfu/ Plate
Monitoring once a week (Self)
Pressure in
Clean Room
01 Clean Room
20 18 Less than 18
Inside
02 Gray Zone 35 33 Less than 33
03 White Zone 20 18 Less than 18 Thrice a day
04 Staging
05 03 Less than 03
Room
Pressure in
Microbioloical
(LAB)
01 Staging
05 03 Less than 03
Room
02 Change
20 18 Less than 18
Room 1st
03 Change
35 33 Less than 33
Room 2nd Thrice a day
04 Buffer Room 50 48 Less than 48
05 Laminar
30 28 Less than 28
Room
06 Less than 38
Change III 40 38
07 Media
35 32 Less than 32
Preparation
08 Change
20 18 Less than 18
Room 1st
4.1.1.5 Alert Limit: The following alert limits to be observed while

production is on. In case pressure drop below alert limit we
should stop the production and investigate the reason for the
same and followed by corrective action.
4.2 Monitoring of Bio-burden Using Petri Dishes.



4.1.2 The following test must be done on monthly basis.

4.1.2.1 Prepare nutrient agar medium with appropriate water to sterilize
121°C for 15 minutes.
4.1.2.2 Pour approx. 25ml media at a temperature around 60°C in to
petridish under a laminar air flow.
4.1.2.3 Allow the media to solidify and cover the petri-dish.
4.1.2.4 Expose petri-dishes in clean areas which are fumigated and
sanitized. 19 petri dishes to be placed at per location chart
(INSP/F26A, B, C).
4.1.2.5 Expose for 2 hours removing the cover of petridish.
4.1.2.6 Finger impressions, Dress impression of different operator are
also taken.
4.1.2.7 The floor, working table and wall impression also taken at
different places.
4.1.2.8 Plate will be exposed as per the approved lay out plan.
4.1.2.9 One petri-dish plate is also incubated for negative control.
4.1.2.10 Microbial count of compressed air also checked.
4.1.2.11 Microbial count of personnel also checked at least one male and
one female twice a week.
4.1.2.12 Plate should be exposed twice a week for environmental
monitoring and floor, working table and wall should monitored
twice a month (INSP/F19).
4.2 Incubation of petri – dishes and Colony Counting.
4.2.1 Cover the petri dishes and incubate at 30-35°C for 48 hours and at 20-
25°C for further 72 hours. Remove dishes from incubator, count the
bacterial colonies developed after 48 hours of incubation at 30-35°C
and fungal colonies after 72 hours of further incubation at 20 – 25°C
and record these findings.
4.3 Interpretation of result

All products are being terminally sterilized. If colony counts are higher
than above limits, corrective actions are to be taken by increasing
sanitization and fumigation etc.
Bacterial Count Fungal Count
Alert limit Action Limit Alert limit Action Limit
AREA
(CFU) (CFU) (CFU) (CFU)
Dispensing 40 50 Nil Nil
Clean Room 40 50 Nil Nil
Microbiological 40 50 Nil Nil
(LAB)
Control of fumigation for clean room


4.3.1 Control on Personnel Hygiene and Sanitation of Employees Working in

the Clean Room.
4.3.2 Personnel hygiene / cleanliness instructions
4.3.2.1 Entry to the clean room section is allowed to the authorized
personal only. The entrants are expected to wear well-cleaned
clothes, proper cut hair & nails. Regular checking of workers.
4.3.2.2 Wash their hands with antiseptic solution available in washing
area.
4.3.2.3 After washing hands dry the hands with hand dryer
4.3.2.4 Wear the Clean Room Dress. (A lint free & well-cleaned uniform
(overall and head –covering).
4.3.2.5 It shall be ensured that workmen is free from any type of
contagious disease. Yearly medical checkup is carried out by the
company as per company schedule.
4.3.2.6 After entering the room workmen should have to clean the work
table/ instrument/ machine with cleaning solution before starting
the work. The same will be repeated while leaving the worktable
after completing the duty.
4.3.3 The Uniform (overall & Head –Covering), Shall Be Lint Free and Well
Cleaned Once in A Week (PRD/F12). The Above Cleaning / Washing
Is Arranged by The Out Side Party.
4.3.4 Clean room section cloth shall not be worn in non-classified area.
4.3.5 The floor of the clean room should be swabbed daily with the antiseptic
liquid.
4.3.6 The electric & electronic fixtures such as tube light, telephone etc. are
cleaned under the supervision of electrician. During such cleaning
packaging material, products are stored in coverings.
4.4 Environment Control Instructions

4.4.1 Smoking chewing, eating & drinking is not allowed in factory premises.
4.4.2 It shall be ensured daily by in-charge and quality control. that the clean
room section is free from dust. Windows are permanently closed.
4.4.3 Doors are always kept closed except while entering/leaving the clean
room. The entire packaging materials/containers/ equipment/
instrument being entered to the clean room shall be dust free
(PRD/F6).
4.5 Sanitation and general housekeeping in the clean room cleaning frequency
4.5.1 Control on the air coming through HEPA filters from the air handling
units.
4.5.2 For ensuring the clean air inside the clean room, the air comes through
the air-handling unit with HEPA filters placed.


4.5.3 Pre filters of all AHU to be cleaned as per the approved schedule,
regularly (MNT/F06).
4.6 Control on the material movement in and out of the clean room
4.6.1 The entry and exit of the material and components respectively are
highly controlled in the clean room. All the components coming inside
the clean room are transferred through the dynamic pass box after the
UV light treatment to ensure the disinfection of the material (PRD/F07).
All the finished products are also transferred through the dynamic pass
box only.
5. Reference
ISO 13485:2016 Clause 7.5.1. & Schedule M ISO 14644-1 in respective area.
6. Forms/Formats
Clean Room Cleaning Log Book PRD/F07A
Bio-burden of Clean Room INSP/F06
Validation Master Plan EMS-01A
Environmental Monitoring INSP/F17A
7. Revision History
Revision No. Reason for Change
01 Incorporation of Corporate office address in Header of the SOP format
00 New issuance of SOP with review date information on header.
Revise the SOP as per requirement of ISO 13485:2016 & ISO 9001:2015
8. Distribution Record
Copy No. Department
Master Copy Quality Assurance Department
Controlled Copy 01 Quality Control Department
Controlled Copy 02 Production Department


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B L LIFESCIENCES PVT. LTD.

Standard Operating Procedure

Reviewed by Priyanka Sachan Manager QA 01-07-2022

Approved by Hemant Singh GM Operations 01-07-2022

Standard Operating Procedure

Integrity test agency)

4.1.1.5 Alert Limit: The following alert limits to be observed while

4.2 Monitoring of Bio-burden Using Petri Dishes.

Reviewed by Priyanka Sachan Manager QA 01-07-2022

Approved by Hemant Singh GM Operations 01-07-2022

Standard Operating Procedure

4.1.2 The following test must be done on monthly basis.

4.3 Interpretation of result

Reviewed by Priyanka Sachan Manager QA 01-07-2022

Approved by Hemant Singh GM Operations 01-07-2022

Standard Operating Procedure

4.3.1 Control on Personnel Hygiene and Sanitation of Employees Working in

4.4 Environment Control Instructions

Reviewed by Priyanka Sachan Manager QA 01-07-2022

Approved by Hemant Singh GM Operations 01-07-2022

Standard Operating Procedure

Name Designation Signature Date

Reviewed by Priyanka Sachan Manager QA 01-07-2022

Approved by Hemant Singh GM Operations 01-07-2022

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