Standard Operating Procedure for Use of Personal Protective Equipment (PPE) in Dispensing Areas
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/104/2025 |
| Supersedes | SOP/SIM/104/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To ensure all personnel involved in material dispensing for sterile injectable manufacturing wear appropriate Personal Protective Equipment (PPE) to prevent contamination and protect operator health and safety.
2. Scope
This
SOP applies to all personnel entering and operating in dispensing booths, weighing rooms, and adjacent Grade D areas involved in sterile manufacturing processes.
3. Responsibilities
- Operators: Properly don PPE as per procedure and report any damage or deviation.
- Production Supervisor: Ensure availability of PPE and monitor compliance.
- QA Personnel: Perform routine checks and audits of PPE compliance.
4. Accountability
Production Head is accountable for ensuring PPE compliance during dispensing operations.
5. Procedure
5.1 Entry Protocol
- Enter the gowning area in designated footwear and uniform.
- Perform handwashing and sanitization before donning PPE.
5.2 Required PPE Items
- Disposable bouffant cap / hood
- Sterile face mask (3-ply or N95 based on material)
- Full-body coverall or disposable gown (non-shedding)
- Sterile powder-free gloves (double layer where required)
- Goggles or safety glasses
- Shoe covers or designated sterile area footwear
5.3 Donning Sequence
- Hair cover → Face mask → Inner gloves → Gown → Goggles → Shoe covers → Outer gloves
- Ensure tight seal of mask around nose and chin.
- Sanitize gloves with 70% IPA every 30 minutes during activity.
5.4 During Operation
- Do not touch face, mask, or adjust PPE once inside the dispensing booth.
- If PPE is torn or damaged, exit the area immediately and replace with fresh set.
5.5 Doffing and Disposal
- Remove PPE in the reverse order and dispose of in biohazard or non-hazard bins as applicable.
- Document usage in PPE issuance log (Annexure-1).
6. Abbreviations
- PPE: Personal Protective Equipment
- IPA: Isopropyl Alcohol
- SOP: Standard Operating Procedure
7. Documents
- PPE Issuance and Usage Log – Annexure-1
- Dispensing Room Entry Checklist – Annexure-2
8. References
- OSHA PPE Guidelines
- EU GMP Guidelines Annex 1
- Company Safety Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: PPE Issuance and Usage Log
| Date | Employee Name | PPE Issued | Time In | Time Out | Remarks |
|---|---|---|---|---|---|
| 18/06/2025 | P. Sharma | Gown, Mask, Gloves | 08:30 | 12:00 | Used properly |
Annexure-2: Dispensing Room Entry Checklist
| Item | Status (Y/N) | Remarks |
|---|---|---|
| Hair covered | Y | ✔ |
| Face mask sealed | Y | ✔ |
| Goggles worn | Y | ✔ |
| Hands sanitized | Y | ✔ |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Release | New SOP | Head QA |
| 18/06/2025 | 2.0 | Updated donning sequence and logs | Compliance Update | Head QA |