The Laboratory

A separate Chemical and Microbiological Laboratory is present

A number of tasks are undertaken in the Chemical Laboratory as follows:

1. Carry out all routine Q.C. Analytical work on raw materials, work-in-progress and finished goods.

2. Operate, maintain and oversee calibration of all Laboratory instrumentation and equipment ( including HPLC, u/v spectrophotometer, infra-red spectrophotometer, autotitrator).

3. Carry out product stability testing as required and manage the ongoing product stability testing programme.

4. Carry out the Validation work in the areas of Process, Analytical Method and Cleaning Validation, as required.

5. Participate in the development to optimisation of the new processes and analytical methods.

Microbiology Laboratory

The Microbiology Laboratory is divided into 2 main testing suites:-

1. Product Sterility Testing Suite

2. Routine Microbiological Analysis

1. Final product sterilility testing is conducted in the Product Sterility Testing Suite.

2. Routine Microbiological Analysis comprises:

a) Bioburden testing of raw materials used for the parenteral products and monitoring of the production process by bioburden testing at the compounding stage, post filtration and at the filling stages.

b) Determination of the Bioburden on incoming bottles, vials, closures and seals used for parenteral products.

c) Environmental Monitoring of Production areas - placement of settle plates and trend analysis of results.

d) Microbial testing of Purified Water Supply and Water for Injections. Pyrogen testing using Limulus Amebocyte Lysate ( LAL) test for WFI Water Supply and for some end product Pyrogen Testing.