Standard Operating Procedure for Use of Humectants in Lyophilized Products
1) Purpose
This SOP outlines the process of incorporating humectants into lyophilized products to ensure moisture retention and stability during storage and reconstitution.
2) Scope
This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized products requiring humectants.
3) Responsibilities
- Formulation Scientists: Responsible for selecting humectants based on the moisture retention needs of the formulation.
- Operators: Responsible for incorporating humectants as outlined in the Batch Manufacturing Record (BMR).
- QA: Responsible for verifying the incorporation of humectants and ensuring proper documentation.
4) Procedure
4.1 Selection of Humectants
4.1.1 Criteria for Selection
- 4.1.1.1 Humectants must ensure moisture retention and prevent excessive drying of the lyophilized product. Common agents include glycerol and propylene glycol.
4.2 Incorporation of Humectants
4.2.1 Weighing and Dispensing
- 4.2.1.1 Weigh the required amount of humectants using a calibrated balance as specified in the BMR.
- 4.2.1.2 Add the humectants to the formulation solution while stirring to ensure even distribution.
4.2.2 Mixing and Homogenization
- 4.2.2.1 Stir the solution using a mechanical stirrer to ensure the humectants are evenly distributed throughout the formulation.
- 4.2.2.2 Homogenize the mixture if necessary to ensure uniformity across the entire batch.
4.3 Filtration and Filling
- 4.3.1 Filter the solution using
a sterile 0.22-micron filter and fill into vials as per the BMR for lyophilization.
4.4 Documentation
Record all steps, including the addition of humectants, filtration, and lyophilization parameters, in the Humectant Incorporation Logbook and ensure QA verification.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Humectant Incorporation Logbook
7) References
- Pharmacopoeial guidelines for the use of humectants in lyophilized products
8) SOP Version
Version 1.0
Annexure
Humectant Incorporation Logbook Template
| Date | Humectant Name | Batch No. | Quantity | Operator Initials | QA Verification |
|---|---|---|---|---|---|
| DD/MM/YYYY | Humectant Name | Batch Number | Quantity (grams) | Operator Name | QA Initials |