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.
Arbro’s pharmaceutical microbiology testing ensures that the raw materials used in drugs match the standard quality requirements before they are processed in the production environment.
Our microbiologists also validate the methods used for testing finished products as well as monitor the quality of air and water from the microbiological perspective.
Pharmaceutical Microbiology Testing Services at Arbro
We provide pharmaceutical microbiology testing services to manufacturers of both sterile and non-sterile pharmaceutical products and substances. Our laboratories are well equipped and carry out all the required microbiological testing for pharmaceutical industry including –
Sterility testing is an essential microbiology testing requirement that ensures sterile pharmaceuticals, medical equipment and substances are safe for use. We offer two sterility testing methods:
- Direct Inoculation
- Membrane Filtration
Bacterial Endotoxin Testing by LAL Test:
Limulus Amoebocyte Lysate (LAL) test is performed to check and quantify bacterial endotoxins that are extracted from the products.
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 milliliter.
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.
This is done to determine the efficiency of antibiotics.
It is important to determine the potency of vitamins.
Assay for Probiotics like Lactobacillus:
It is used for the total viable count. It is important to ensure that the product is fit for human consumption.
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.
We use plate exposures and air sampling methods for environmental monitoring.
Microbiological Water Testing:
Microbiological testing of water is done during different phases of water system validation
Total Viable and Non-Viable Particle Count in Large Volume Parenterals
This is a critical test and is a mandatory pharmacopoeial requirement. Either a microscopic particle count or a light obscuration liquid particle counter is used to perform this test.
Development and Validation of Microbiological Testing Methods:
We have the knowledge and experience to carry out the development and validation of microbiological testing methods.
Species Identification of House Organisms:
Identifying and monitoring indoor microbes is important for health and safety purposes.
Our Microbiology Testing Facilities
We have three state-of-the-art pharmaceutical microbiology testing laboratories located in New Delhi, Baddi (Himachal Pradesh) and Bangalore (Karnataka). Our laboratories are designed as per the latest requirements with clean rooms, unidirectional flow, AHUs, Terminal HEPA filters and epoxy flooring.
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.
We are approved by the State FDA and Central Drugs Standards Control Organisation (CDSCO) for the testing of drugs and cosmetics and can also provide reports on form 39 for pharmaceutical microbiology testing.
Our microbiology lab is also accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) for the testing of pharmaceutical products.
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 of data on which you can rely and ensure patient safety as well as regulatory compliance.
Please feel free to contact us using the quick query form on the right or by calling us now on +91-11-45754575!
1. Do you conduct sterility testing?
We offer both direct inoculation and membrane filtration methods for sterility testing. These methods ensure the safety and sterility of your medical equipment, pharmaceuticals, and other substances so that you do not face any trouble regarding the presence of viable microorganisms in your products at any later stage. Early sterility testing microbiology also keeps you secure from making unnecessary expenditures on impractical substances.
2. Do you conduct an endotoxin test by the LAL method?
Yes, our experts conduct bacterial endotoxin testing by the LAL (Limulus Amoebocyte Lysate) method to analyze and check the quantity of bacterial endotoxins in pharmaceutical products. This is extremely crucial to ensure that the substance is safe for human consumption, and it won’t cause any toxic effects, such as a rise in body temperature.
3. Can you perform validation of microbial limit tests?
Yes our team can conduct Method Validation Studies for microbial limit tests in your products.
4. Can you perform preservative efficacy testing?
Our experts can perform preservative efficacy testing to find the type and minimum possible concentrations of preservatives that can be used for the appropriate storage of your pharmaceutical products so you won’t have to deal with any product or test-related problems in the future.