Leveraging analytical instruments for Higher Quality and Larger Volume
At Wembrace Biopharma, we are well-equipped for high-quality and high-volume production with the help of sophisticated imported analytical instruments. Our liquid and lyophilized injection section includes imported machinery from leading pharmaceutical equipment manufacturers from IMA, Italy. Our equipment includes HPLC from Waters to precisely identify the compositions of mixtures, a Polarimeter from Rudolf to determine the purity of ingredients, Gas Chromatography, FTIR, AAS and a UV Spectrophotometer from Perkin Elmer and Karl Apparatus Stability Chambers. Our laboratory instruments ensure that we produce highly potent yet safe pharmaceuticals.
Our production equipment helps us to speed up the manufacturing process efficiently. The sophisticated instruments used in the manufacturing process ensure accurate testing of our products and maintain a high level of quality. Our facilities manufacture 48,000 vials of liquid injections per shift and approximately 20,000 vials of lyophilised injections per cycle. Our Microbiology section is equipped with a double-door autoclave, closed system sterility, LAFs, Zone Reader, LBPC and TOC for efficient production, faster and more accurate testing and quality control.
Stability Section
Our capabilities also include the Stability Section, headed by the Head of Quality Assurance. This section performs stability studies for:
- Introducing a new product or process
- Changing the manufacturing process or critical process parameters
- Changing the vendors of key raw materials or the starting material
- Changing critical equipment in the manufacturing process
- Changing the facility or location
- Making significant changes in the batch size
- Changing the packaging configurations
- Changing storage conditions
The Quality Assurance department decides the criteria for the selection of batches and the type of stability study to be performed. The Head then approves the stability data of the reviewed batch of QA before being submitted to the Regulatory department.
Microbiology Department
The Microbiology Department is part of the Quality Control Department, comprising trained staff working in an adequate facility with instruments and approved methods for:
- Monitoring the environment
- Sampling and testing raw materials, packing materials and finished products
- Testing water samples
Records of every activity is maintained for quality assurance.
