Gel Manufacturing: SOP for Environmental Monitoring in Gel Manufacturing Area – V 2.0

Standard Operating Procedure for Environmental Monitoring in Gel Manufacturing Area

Department	Gel Manufacturing
SOP No.	SOP/GM/172/2025
Supersedes	SOP/GM/172/2022
Page No.	Page 1 of 10
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To establish a documented procedure for environmental monitoring in the gel manufacturing area, including air, surface, and personnel monitoring, to ensure microbial and particulate contamination control.

2. Scope

This SOP applies to all manufacturing areas designated for gel production and filling, including cleanrooms and controlled environments.

3. Responsibilities

Microbiology Analyst: Responsible for performing environmental monitoring activities.
Quality Control (QC): Ensures the trend analysis and out-of-specification (OOS) management.
Quality Assurance (QA): Oversees compliance and investigates deviations.
Production Department: Facilitates access to areas and ensures readiness for monitoring.

4. Accountability

The Head

of Quality Control is accountable for implementing and maintaining the environmental monitoring program.

5. Procedure

5.1 Monitoring Types and Frequency

Viable Air Monitoring: Perform using settle plates and active air samplers weekly in critical areas and monthly in non-critical areas.
Non-Viable Particle Monitoring: Perform with particle counters in Class 100, 1000, and 10,000 environments daily during operations.
Surface Monitoring: Conduct using contact plates (RODAC) on walls, floors, machines, and equipment weekly.
Personnel Monitoring: Execute finger dab testing post-operations for all production personnel at least weekly.

5.2 Sample Collection and Incubation

Label each media plate with date, time, location, and analyst initials before exposure.
Settle plates: Expose for 4 hours at designated locations in critical processing areas.
Contact plates: Apply to surface areas (~25 cm²) with firm and even pressure.
Incubate plates at 30–35°C for 48–72 hours followed by 20–25°C for 72 hours to capture bacterial and fungal growth respectively.

5.3 Acceptance Criteria

Refer to ISO 14644 and internal microbial limits based on room classification.
Document results and compare against alert and action limits.
Generate deviation reports for all OOS results and initiate CAPA.

5.4 Documentation and Trending

Record results in the Environmental Monitoring Log – Annexure-1.
Summarize data in the Environmental Monitoring Summary Sheet – Annexure-2.
Review monthly trends and submit Environmental Monitoring Report – Annexure-3 to QA.

6. Abbreviations

QC: Quality Control
QA: Quality Assurance
OOS: Out-of-Specification
RODAC: Replicate Organism Detection and Counting

7. Documents

Environmental Monitoring Log – Annexure-1
Environmental Monitoring Summary Sheet – Annexure-2
Environmental Monitoring Report – Annexure-3

8. References

ISO 14644-1: Cleanroom Classification
WHO TRS 961 Annex 6: GMP for Sterile Pharmaceutical Products
Schedule M – Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Microbiologist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Environmental Monitoring Log

Date	Location	Type	Result (cfu)	Analyst
		Settle Plate / RODAC / Air Sampler

Annexure-2: Environmental Monitoring Summary Sheet

Month	Area	Total Samples	OOS Samples	Comments

Annexure-3: Environmental Monitoring Report

Month
Reviewed By
Approved By
Summary of Trends

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/04/2022	1.0	Initial version	New SOP	QA Manager
09/06/2025	2.0	Updated sampling procedures	Compliance with ISO 14644 and WHO GMP	QA Manager