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 state-of-the-art machinery from leading pharmaceutical equipment manufacturers from IMA, Italy. Our equipment includes.
- HPLC from Waters to precise identification of mixture compositions.
- Polarimeter from Rudolf to determine ingredients purity.
- Gas Chromatography,
- FTIR,
- AAS,
- UV Spectrophotometer from Perkin Elmer, 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 production capabilities enable us to manufacture 48,000 vials of liquid injections per shift and approximately 20,000 vials of lyophilized 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 Stability Section, overseen by our Head of Quality Assurance, conducts comprehensive stability studies. These studies are crucial 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
Our Quality Assurance department establishes criteria for batch selection and determines the appropriate type of stability study. Subsequently, the Head of Quality Assurance approves stability data for review by 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.
