Microbiology
At Alapati Pharma, our dedicated microbiology team performs rigorous microbial testing to maintain product integrity, efficacy, and patient safety.
Key Areas of Microbiological Quality Control
- Raw Material & Water Testing
- We conduct microbial contamination tests on all raw materials, excipients, and water sources to ensure that only pure and high-quality components are used in manufacturing.
- Our facility is equipped with a Closed-Loop SS 316 Water System with RO & DM Plants to maintain zero microbial contamination.
- Environmental Monitoring & Cleanroom Validation
- We perform regular air and surface monitoring to prevent microbial contamination in production areas.
- Our cleanrooms are equipped with dedicated HVAC systems and HEPA filtration to maintain controlled environments.
- In-Process Microbial Testing
- At every stage of production, we conduct bioburden testing, sterility tests, and endotoxin testing to ensure that microbial contamination is within acceptable limits.
- Final Product Microbial Analysis
- Before commercial release, each batch undergoes microbial limit testing to confirm that it meets regulatory standards for safety and efficacy.
- We also conduct stability studies to assess microbial growth over the product's shelf life.
Advanced Microbiology Lab & Testing Equipment
Our state-of-the-art microbiology lab is equipped with:
- Laminar Air Flow (LAF) Systems – To ensure contamination-free testing environments.
- Autoclaves & Sterilization Units – For proper sterilization of media and equipment.
- Incubators for Microbial Culture Growth – To test for potential contamination.
- Endotoxin Testing Equipment – To check for bacterial endotoxins in sterile products.
