The sterility testing isolators are of immense importance in Canada and other parts of the globe because of their usage in testing, quality control, and quality assurance in Pharmaceutical and other industries. Apart from the production of certain drugs, including eye drops or ophthalmic that need to be tested on the stability parameters, other Pharmaceutical products, and medical devices should also be checked for sterility and their pathogenic content.
The Food and Drug Administration or FDA has strict guidelines and regulations that detail how every Pharmaceutical manufacturer has to follow to get the drug approved and to make them safe enough to be sold in the market.
The new ISO Certified sterility testing isolators Canada undergo the environmental control and monitoring programs as well, and can provide for sterility testing and lesser errors and deviations during Pharmaceutical production.
Variations or Types of Sterility Testing
The three important variations of sterility testing include:
Direct inoculation or immersion – Direct inoculation involves testing of a given product or article into different kinds of media that provide for the growth of aerobic and the anaerobic microorganisms. The incubation period is 14 days after which laboratory tests for the detection of microorganisms are carried out. This method can be used for virus banks, and bulk, and banking cells, among other pharmaceutical products.
Membrane filtration – Effluent and the bulk articles can also be passed through a membrane which retains the microorganisms. Test samples that have a larger volume can be tested using the membrane filtration method.
Direct transfer – Creams, solid dosage products, and the medical devices are directly placed in the medium of growth and their fungistatic and bacteriostatic properties are checked and tested. The period of inoculation is 14 days.
Types of Isolators
Isolators are a preferred choice for sterility testing as they separate the laboratory processing environment from the facilities which surround it, to a greater extent. The two major kinds of isolators include:
Closed isolator – The closed isolator system can completely overcome the exterior contamination of the substances to be tested; Samples are transferred to the interior of the isolator by the use of aseptic connections and auxiliary extensions that are completely sterile. There are no openings from which bacteria virus and other pathogens from the surroundings can reach to the interior of the isolator. As the systems remain closed while performing the operations, the threat of contamination is further decreased.
Open isolator –Open isolators are connected to the external surroundings through openings but as continuous pressure is applied they remain contamination free. They are useful for testing conditions where samples have to be continuously fed into the isolator for testing.
The threat caused by microorganisms and pathogens can be very grave and lead to death as well. Hence it is all also legally mandatory for each Pharmaceutical manufacturer to ensure that the products are free from pathogens and fit for human use.
Apart from ophthalmic, parental drugs, injections and other Pharmaceutical preparations should also be tested thoroughly by using the isolated systems to attain a higher degree of sterility. The sterility testing isolators Canada are also used to ensure compliance while making the products fit for human usage.