Gelken issues guidance on pharmaceutical gelatin storage
Gelken has released a guide on the proper packaging, storage, and inspection of pharmaceutical gelatin to maintain its quality.
Gelken, a manufacturer of pharmaceutical-grade gelatin, has published detailed guidance on best practices for storing and handling pharmaceutical gelatin. The guidance emphasizes the importance of appropriate packaging, controlled storage conditions, incoming inspection, and management of retest or expiry dates.
The company highlights that pharmaceutical gelatin must retain its specified quality from receipt through use. Buyers and manufacturers are advised to protect the dry ingredient, maintain traceable records, and confirm its release status before production. Gelatin's suitability for pharmaceutical use is defined by attributes such as gel strength, viscosity, moisture content, and microbiological quality, which can affect processing and dosage-form performance, including finished product dissolution.
According to the guide, controlling moisture and heat exposure is central. Moisture uptake can lead to caking and microbial growth, while excessive heat can affect functional properties. Gelken recommends maintaining specific temperature and humidity limits in storage areas and protecting against direct sunlight and heat sources. Packaging integrity and proper resealing of opened containers are also crucial.
The company advises translating supplier storage instructions into warehouse limits and monitoring arrangements. Warehouse qualification and risk assessment should be used to determine appropriate monitoring locations and frequency. Control of key parameters such as temperature, relative humidity, packaging integrity, and light exposure is essential.
Furthermore, Gelken stresses the significance of incoming inspection and quarantine. Incoming gelatin should be placed under quarantine until necessary checks and tests are completed and authorized for use. This stage also involves reviewing the Certificate of Analysis (CoA) to ensure it aligns with approved specifications. Inspecting the condition of packaging, seals, and labeling is also part of the process.