Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store
Objective
To lay down a procedure for Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store to prevent them from drying and embattlement or the absorption of moisture.
Scope
This Standard Operating Procedure is applicable in Raw Material Store for the proper storage of Empty Hard Gelatin Capsule Shells at the formulation plant.
Responsibility
Raw Material Store personnel shall be responsible for following the procedure mentioned in this SOP.
The raw Material Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.
Accountability
Raw Material Store in charge & QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA: Quality Assurance
Ltd.: Limited
PVC: Poly Vinyl Chloride
Procedure
Empty Hard Gelatin Capsules Shells are transported under controlled conditions of temperature and humidity i.e. in ‘REFRIGERATED CARGO’. Capsule shells are tightly air-sealed in PVC air-tight bags. These bags are put into Corrugated Boxes. Adhesive tape is put on all the sides of Corrugated Boxes to seal the joints and to make the box airtight. After the receipt of empty hard gelatin capsule shells, the following steps are followed:
Shift these corrugated boxes to a Quarantine Area that has controlled conditions that is humidity and temperature.
- Let the Empty Hard Gelatin Capsule Shells be sampled out by Quality Control for testing.
- After sampling seal the bags and corrugated boxes airtight.
- Wait for the testing report of Quality Control Department.
If the results of the empty hard gelatin capsule shells ‘Passed’ then transfer them to an approved area in Raw Material Store with controlled temperature and humidity conditions.
Otherwise, shift the rejected capsules to the rejected Raw Material Store also affix a red colored “Rejected” Status Label.
The Empty Hard Gelatin Capsule Shell shall be stored at a temperature of 25 ± 2˚C.
The empty hard gelatin capsule shells shall be stored at relative humidity 55% ± 5 %.
Maintain the controlled conditions that is temperature and humidity for storage of empty Hard Gelatin capsule shells in Raw Material Quarantine and Raw Material dispensing and storage areas because of the factors ahead:
At high moisture levels the capsules absorb moisture, become soften, tacky and deform under their own weight.
At low moisture levels, capsules become brittle and suffer dimensional changes.
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Raw Material Store
History
