Sangene Biotech provides a range of Microbiological testing and Support services to Pharmaceutical companies ensuring that the Samples are appropriately monitored for Microbiological contamination and Evaluation of activity meeting all Regulatory requirements. Our dedicated GMP compliant laboratories, Experienced Professional team with vast expertise, and Extensive range of microbiological tests provide cost-effective and simplified Quality Control solutions across the Healthcare Industry from the Manufacturing Environment to the Products including Tablets, Capsules, Injections, Ointments, Ophthalmic’s, Syrups, Medical devices etc for the best results.
The Following Tests are taken up at our Facility Including but not Restricted to:
- Raw Material
- Finished Product
- Stability Studies
- Environmental monitoring
- Water testing and validation
- Method Validation
Bacterial Endotoxin Testing by LAL Test
Limulus Amoebocyte Lysate (LAL) test is performed to check and quantify bacterial endotoxins that are Present in Water, Injectables and Products.
Time Kill Studies
Time-Kill In Vitro assay tests are referred to as “suspension tests” because a measured volume of the suspension of challenge bacteria or fungi is transferred into a liquid test material, dilute or “neat,” to determine how rapidly a challenge species is killed. These same procedures are applied, in principle, to testing surface-active antimicrobials per ASTM and AATCC methods.
Microbial Limit Tests
Microbial contamination testing is performed for non-sterile products in which harmonised pharmacopoeia or client-supplied methods are used that determine the bioburden within the sample.
Total Bacterial Counts
Total bacterial count indicates the number of microorganisms present in a sample. The number of microorganisms should not be greater than the specified guide values that are expressed in CFU (colony-forming units) per gram or ml.
Total Fungal Counts
It indicates fungal count present in a sample. Monitoring this is important to know about the fungal contamination in pharmaceuticals.
Detection of Pathogens
Detection of pathogens in pharmaceuticals finished products and Raw materials is important for the safety and well-being of the consumers.
Antibiotic and Vitamin Assay
This is done to determine the Efficiency or Potency of Antibiotics and Vitamins as Raw materials and in the Finished product
Preservative Efficacy Testing
This test is performed to check the type and minimum effective concentration of Preservative that is required for satisfactory preservation of pharmaceuticals.
Air Monitoring
Exposures and Air sampling methods for Environmental monitoring. Identifying and monitoring indoor microbes is important for health and safety purposes in Pharmaceuticals Production/Clean rooms, Hospital Environment/Operation Theatre’s/ ICU’s, Food Processing/Packaging areas, Co-Work spaces, Apartments, Child Care units, Hotels etc. Microbial Enumeration of Instrument surface area.
Disinfectant Efficacy Testing
Phenolic and non-phenolic type of disinfectants are tested for their germicidal value against Pathogens as per National and International protocols.
Microbiological Water Testing
Microbiological testing of water is done during different phases of water system validation.
Development and Validation of Microbiological Testing Methods
To carry out the Development and Validation of Microbiological testing methods.
Stability Studies
Non-Sterile products are tested for its microbial load over a period of time to check for its Shelf life.
Lactobacillus Assay
To Enumerate and Determine Lactobacillus count in Probiotic products. Identify Lactobacillus species using PCR based assay
Species Identification of In-House Organisms
Identification of specific organism which are used in Production or a contaminant using Vi-tek system or PCR based assay.
Method Validation
Validation of microbial processes for new Non sterile products can be taken up to assess the testing process
AATCC 100 Testing
We Conduct tests that are used to evaluate the efficacy of antibacterial properties in Textiles and Fabrics or any other Product prescribed, by challenging the same with various Microbial strains.
