Standard Operating Procedure for Weighing and Dispensing Raw Materials
1) Purpose
This SOP outlines the procedures for accurately weighing and dispensing raw materials used in nanoparticle formulations. The aim is to ensure the correct quantities are measured and handled safely to avoid contamination or errors in formulation.
2) Scope
This SOP applies to all operators and staff involved in the weighing and dispensing of raw materials in the production of nanoparticle formulations.
3) Responsibilities
- Operators: Responsible for weighing and dispensing raw materials accurately according to the batch record or formulation guidelines.
- QA: Ensures that weighing and dispensing procedures follow established standards and quality protocols.
4) Procedure
4.1 Equipment Setup
4.1.1 Calibration of Weighing Equipment
- 4.1.1.1 Ensure that all weighing scales are calibrated before use. Calibration records must be checked and updated before weighing any materials.
- 4.1.1.2 Use appropriate calibration weights as per the equipment manufacturer’s guidelines.
4.1.2 Cleaning of Equipment
- 4.1.2.1 Clean all weighing surfaces, containers, and tools before use to avoid cross-contamination.
- 4.1.2.2 Ensure the work area is free from any previous materials or residues that could interfere with the current batch.
4.2 Weighing Procedure
4.2.1 Weighing of Raw Materials
- 4.2.1.1 Carefully weigh each raw material according to the quantities specified in the batch record. Always use a clean, dry container for each material.
- 4.2.1.2 Record the weight of each material in the raw material weighing logbook, ensuring it matches the required quantity.
- 4.2.1.3 If there is any deviation in weight, document and report it to the supervisor or QA for review.
4.2.2 Dispensing Raw Materials
- 4.2.2.1 After weighing, dispense the raw materials into clearly labeled containers for each stage of the formulation process.
- 4.2.2.2 Ensure that all containers are sealed and transported properly to prevent spillage or contamination.
4.3 Safety Considerations
4.3.1 Personal Protective Equipment (PPE)
- 4.3.1.1 All operators must wear appropriate PPE, including gloves, masks, and lab coats, to prevent contamination and ensure personal safety.
4.3.2 Handling Hazardous Materials
- 4.3.2.1 For any hazardous or volatile materials, handle them inside a fume hood or well-ventilated area and follow all safety guidelines as per the MSDS.
5) Abbreviations, if any
- PPE: Personal Protective Equipment
- QA: Quality Assurance
- MSDS: Material Safety Data Sheet
6) Documents, if any
- Raw Material Weighing Logbook
7) References, if any
- Good Manufacturing Practice (GMP) Guidelines for Pharmaceuticals
- MSDS for raw materials
8) SOP Version
Version 1.0
Annexure
Raw Material Weighing Logbook Template
| Date | Material Name | Batch Number | Weight Dispensed | Operator Initials | QA Initials |
|---|---|---|---|---|---|
| DD/MM/YYYY | Material Name | Batch Number | Weight in grams | Operator Name | QA Name |