March 2023

Microbial stability testing involves the following five steps: Sampling : The number of containers to be used and volume to be tested are specified in the Pharmacopoeia. Samples of aseptically manufactured product are collected in the beginning of, during, and end of batch fill, and also after any kind of interventions and stoppages. Samples from

Antimicrobial preservatives are added to non-sterile dosage forms to protect them from microbial growth or from microorganisms that are introduced inadvertently during or after the manufacturing process. Antimicrobial preservatives should be added if sterile articles are packaged in multiple-dose containers, thus they inhibit the growth of microorganisms introduced from repeated withdrawal of individual doses. Preservatives

Microbial contamination and spoilage are assessed by the following methods: Physical and Chemical Changes: Microbial contamination and spoilage in various pharmaceutical formulations can be identified by the physical and chemical changes (like change in viscosity, pH, emulsion stability, and loss of surface activity) occurring in it. Amount of oxygen consumed by the available product indicates

Microbiological assays were used for quantitation of amino acids since many years as they were the most reliable, and specific available tests. They can be used for any type of biological material; however sometimes they are affected by the activators or inhibitors present in the material being standardised. These inexpensive methods are used for analysing

This method relies on the diffusion of an antibiotic from a vertical cavity or a cylinder 2 through the solidified agar layer in a petri plate. The growth of test microorganisms is observed to be inhibited in a circular area or zone around the cavity containing antibiotic solution. The steps involved in cup-plate method are

This method depends on the microbial culture growth in a uniform solution of antibiotic in a fluid medium favourable to its rapid growth in the absence of antibiotic. This method involves a shorter incubation period (4-5 hours) for the growth of test microorganism. However, this assay method is affected by the presence of solvent residues

Antibiotics are the agents that kill or reduce the bacterial growth. They belong to a class of antimicrobials (a larger group also comprising of anti-viral, anti-fungal, and anti- . parasitic drugs). Antibiotics are chemicals either derived from or produced by the microorganisms (i.e., bugs or germs such as bacteria and fungi). The methods of microbiological

The steps by which microbial contamination of products can be prevented in aseptic areas are discussed below: Personnel : They can take the following measures: Access to production areas by the unauthorised personnel should be restricted, and only trained ones should be allowed to enter. Adequate personnel hygiene should be maintained. The personnel should be

There are various contamination sources in an aseptic area, which are discussed below: Personnel : Those supervising, performing, or controlling drug manufacturing are a potential source of microbial contamination, due to the following reasons: Inadequate training, Direct contact between the hands and starting materials, primary packing materials, and intermediate or bulk products, Improper hygiene, Unauthorised