SOP for Weighing and Dispensing of Raw Materials for Nanoparticle Formulations

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