Microbiology Department at ADEPT PHARMA undertakes quality inspection and analysis for industries associated with Drugs, Cosmetics, Pharmaceuticals, Disinfectants and Healthcare products, Raw and processed Food, Water and Beverages as per IS / IP / BP / EP / USP-NF / IS / ISO / WHO / ASTM and Customer methods. The lab is well-equipped, with state-of-the-art facilities and experienced scientists. The lab provides the following services.
1. Microbiological Studies
Â Â a)Â Â Anti-Factor Studies
Â Â b)Â Â Detection of multi-range of PathogensÂ
Â Â c)Â Â Bacterial Endotoxins TestingÂ
Â Â d)Â Â Disinfection Efficacy Studies
Â Â e)Â Preservative EfficacyÂ Studies
Â Â f)Â Â Sterility TestingÂ
Â Â g)Â Â Bio-Burden Determination
Â Â h)Â Â Microbiological Monitoring of Indoor Air quality (External Services too)
Â Â i)Â Â Water analysis
Â Â j)Â Â Method Validations &Â Method Developments
Â Â k)Â Â Food & Beverages testing
Â Â l)Â Â Microbiological Assay of Antibiotics & Vitamin
a) Total Microbial Count
Microorganisms are ubiquitous in nature. Quality and shelf life of any product depends on presence, and nature of microorganisms contained in it. Under favourable conditions these micro organisms proliferate and result in loss of product quality. Microbiological monitoring is an essential part of quality control. ADEPT PHARMA plays an important role in testing of spoilage micro flora. It includes the test parameters likeÂ
- Standard plate countÂ
- Coliforms / Faecal Coliforms Â
- Psychrophilic and Thermophilic microbes
- Aerobic and Anaerobic Spore FormersÂ
- Anaerobic Bacteria
- Sulphite Reducing Bacteria
- Sulphur and Iron Bacteria
- Yeast and Moulds
- Heat Resistant Moulds
- Proteolytic and Lipolytic Bacterial Count
b) Detection of PathogensÂ
- Escherichia coliÂ
- Vibrio choleraÂ
- Pathogenic streptococciÂ
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Clostridium perfringens
- Bacillus subtilis
- Listeria monocytogenes
- Bile tolerant gram negative bacteria
- Candida albicans
c) Bacterial Endotoxins
Bacteria produce Endotoxins as a part of their metabolic activities. Some of them are heat-labile while others are heat stable in nature. Even severe food processing treatments cannot eradicate these toxicants and may result in intoxication. ADEPT PHARMA undertakes testing of the following Bacterial Endotoxins by Qualitative (Gel-clot method) and Quantitative methods (Turbidometric& Chromogenic methods)
d) Disinfectant Efficacy Studies
Phenolic and non-phenolic type of disinfectants are tested for their germicidal value as per national and international protocols and the test is Redial walker coefficient test
e) Preservative Efficacy Studies
In pharmaceutical, herbal and cosmetic formulations, various anti-microbial substances are added to arrest microbial activity and extend shelf life of the products. The effectiveness of these substances is evaluated as per USP protocols. Selection of challenge micro-organisms includes gram positive and gram negative bacteria, spore formers, yeast and fungi.
f) Sterility Testing
Sterility test is a mandatory requirement for all injectables, ophthalmic preparations and surgical devices & blood products. Sterility test is conducted in accordance with various pharmacopoeias viz. IP, USP, BP by Membrane filtration or Direct Inoculation methods. Following products are tested.
- Parenteral Preparations (Injectables)Â
- Non-parenteral Preparations (Ophthalmic)Â
- Mechanical ContraceptivesÂ
- Surgical Dressings and DevicesÂ
- Blood and its components
g) Monitoring Indoor air
ADEPT PHARMA has well established facility in execution of mega projects in the area of environment all over the country. It is well-equipped with sophisticated & versatile analytical instruments & has updated technology for various analytical applications in the field of environment. ADEPT PHARMA engages highly qualified professionals, exhibiting expertise in respective areas. Laboratories of ADEPT PHARMA will be recognized by various State Pollution Control Boards.
In addition to acceptance tests for the installation of clean rooms in production facilities, routine monitoring also plays a vital role. These measurements help monitor clean rooms as well as production facilities during operation. ADEPT PHARMA offers a broad range of monitoring services for clean rooms, and can also provide customized hygiene-monitoring programs catering to your needs. The services include
- Testing is performed for Air/Clean rooms/ Manufacturing facility/ Equipment/ Personnel.
- Bioburden/Viable count: Settle plate method (4 hrs exposure)
- Aerobic microbial count & combined yeasts & molds by Swab testing (in buffer solution): AMC, Y&M, Coliforms
- Swab Testing (in buffer solution): AMC, Yeast and Molds, Coliforms, E.Coli, Salmonella and Enterobacteriacae.
- Detection of contamination of Bacillus subtilis& Bacillus cereus in pharma products.
- Air Sampling (By air sampler)
- Media plates/swabs for sampling
Bioburden is the sum of the microbial contributions from a number of sources including raw materials, manufacturing of components, assembly processes, manufacturing environment, assembly/manufacturing aids (e.g., compressed gases, water, lubricants), cleaning processes, medical devices and packaging of finished product.
i) Water analysis
The term 'water quality' is used to refer to the physical, chemical and biological characteristics of water. Parameters of water quality are a measure of the condition of water relative to the requirements of one or more biotic species and/or to any human need or purpose. It is most frequently used by reference to a set of standards against which compliance can be assessed. The most common standards used to assess water quality relate to health of ecosystems, safety of human contact and drinking water.