MICROBIAL TESTING
Microbiological testing plays an important role in the production of pharmaceutical drug substances and drug products. Pharmaceutical microbiological testing is essential for patient safety as the patients consuming the medicines might already be in a compromised position and easily susceptible to infections.
Amar Labs pharmaceutical microbial testing lab is BOD and GLP approved and ensures that the raw materials used in drugs match the standard quality requirements before they are processed in the production environment.
🔷 Our Microbiology Testing Facilities -
We have state-of-the-art pharmaceutical microbiology testing laboratories located in Kanpur (Uttar Pradesh). Our laboratory is BOD and GLP approved and designed as per the latest requirements with clean rooms, unidirectional flow, AHUs, Terminal HEPA filters. Other than the physical infrastructure we have a well trained and experienced team and stringent procedures are in place for controlling and monitoring the area as well as all the activities performed in the pharmaceutical microbiology testing laboratory.
We carry out regular calibration and validation of the clean rooms, autoclaves, incubators and all other equipment used in the laboratory. Pharmaceutical microbiology testing is especially important for parental products as they bypass the body’s natural defence mechanisms for protection against pathogens.
We take utmost care to ensure that we provide the highest quality products on which you can rely and ensure patient safety as well as regulatory compliance. Microbial contamination can lead to impaired performance of the product due to disruption of the stability of the formulation, modification of physical characteristics and appearance and lead to inactivation of the active ingredients and excipients in the formulation and also cause loss of confidence in the company. The microbial loads should be established and the contaminants isolated and identified. In addition, alternative methods such as treatment with ethylene oxide or radiation with ionic rays lead to decontamination effects. These methods can be seen as a compromise between ensuring the microbiological safety of the product and avoiding consumer’s risk. It is evident, that, in order to ensure the quality, an important concept for providing the wished security and reliability for its use is required.