Procedure for Handling Volatile Solvents During Dispensing
| Department | Production/Quality Assurance (QA)/Quality Control (QC)/Safety |
|---|---|
| SOP No. | SOP/Ointment/171 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe handling, dispensing, and documentation of volatile solvents in pharmaceutical manufacturing. Proper handling minimizes exposure risks, prevents contamination, and ensures compliance with safety and regulatory requirements.
2. Scope
This SOP applies to all personnel in Production, Quality Assurance (QA), Quality Control (QC), and Safety departments involved in the dispensing, storage, and handling of volatile solvents used in manufacturing processes.
3. Responsibilities
- Dispensing Operator: Handles volatile solvents following safety and GMP protocols.
- QA Officer: Ensures compliance with safety and quality standards.
- Safety Officer: Monitors workplace safety and exposure levels.
- QC Analyst: Tests solvent quality and ensures batch consistency.
- Production Supervisor: Oversees dispensing operations and ensures adherence to procedures.
4. Accountability
The QA Manager and Safety Officer are accountable for ensuring that all volatile solvent handling activities comply with GMP, OSHA, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Selection and Identification of Volatile Solvents
Common volatile solvents used in pharmaceutical manufacturing include:
- Ethanol: Used as a solvent and disinfectant.
- Isopropanol: Used in cleaning and disinfection.
- Acetone: Used in
extraction and purification processes.
Methanol: Used in chemical synthesis.
Toluene: Used in coating and formulation processes.
5.2 Personal Protective Equipment (PPE) Requirements
All personnel handling volatile solvents must wear:
- Chemical-resistant gloves (nitrile or neoprene).
- Protective safety goggles or face shields.
- Lab coats or solvent-resistant aprons.
- Respiratory protection if solvent vapor concentrations exceed safety limits.
- Antistatic footwear when handling flammable solvents.
5.3 Environmental Controls for Solvent Dispensing
- Dispensing must be conducted in **dedicated, ventilated dispensing booths.**
- Fume hoods or local exhaust ventilation (LEV) must be operational at all times.
- Temperature and humidity levels must be maintained per solvent-specific storage conditions.
- Static discharge must be minimized using **grounded dispensing containers.**
- Solvent containers must be labeled with **hazard symbols and batch details.**
5.4 Dispensing Process
- Only **authorized personnel** are allowed to dispense solvents.
- Before dispensing:
- Verify the solvent **batch number and expiry date.**
- Ensure proper ventilation is in place.
- Confirm availability of **spill control kits and emergency eyewash stations.**
- During dispensing:
- Use **closed-system dispensing** to minimize evaporation and exposure.
- Transfer solvents using **dispensing pumps or gravity-fed systems** to reduce spills.
- Do not exceed solvent dispensing **limits as per batch records.**
- After dispensing:
- Immediately cap and seal solvent containers.
- Record the dispensed volume in the **Solvent Dispensing Log (Annexure-1).**
- Dispose of solvent-contaminated materials in **designated waste disposal bins.**
5.5 Safety Measures for Handling Volatile Solvents
- Ensure **no ignition sources** are present in the dispensing area.
- Monitor air quality and solvent vapor concentration using **gas detection systems.**
- Spill control kits, absorbent pads, and neutralizers must be **readily available.**
- Personnel must follow **emergency response protocols** in case of spills or exposure.
5.6 Documentation and Record Keeping
- All solvent dispensing activities must be recorded in the **Solvent Dispensing Log (Annexure-1).**
- Deviations, spills, or unsafe conditions must be reported immediately and logged in the **Incident Report Log (Annexure-2).**
- Records must be maintained for **at least 5 years** and be accessible for audits.
5.7 Emergency Procedures
- In case of solvent spills:
- Evacuate non-essential personnel from the area.
- Use absorbent materials to contain and clean up the spill.
- Dispose of waste as per hazardous waste disposal SOPs.
- In case of exposure:
- Skin contact: Wash affected area with soap and water.
- Eye contact: Flush with water for at least **15 minutes** and seek medical attention.
- Inhalation: Move to fresh air and seek medical help if symptoms persist.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- LEV – Local Exhaust Ventilation
- OSHA – Occupational Safety and Health Administration
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Solvent Dispensing Log (Annexure-1)
- Incident Report Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Safe Handling of Volatile Solvents
- OSHA Standards on Chemical Safety
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Solvent Dispensing Log
| Date | Solvent Name | Batch No. | Volume Dispensed | Operator | QA Review |
|---|---|---|---|---|---|
| 02/02/2025 | Ethanol | ET-1001 | 5L | John Doe | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Solvent Handling Procedures | Improved Safety Compliance | QA Head |