Sterility Isolators

Sterility Isolators

The pharmacopoeias require sterility testing of sterile pharmaceutical products to determine the acceptability of a production batch. It is a fundamental element in the validation of sterilization and should be carried out in such a way as to avoid the risks of false positive and false negative results.

Telstar’s range of rigid wall sterility testing equipment is designed to avoid this risk and protect the product from externally generated factors and the process that could compromise its quality.

The correct ergonomic design of the unit is combined with a sound plan for manufacturing that uses the latest technologies, ensuring easy installation and efficient inspection and testing.

The insulation equipment complies with the ISO 14644-7: 2004 standard, generating an EU-grade BPM environment in the entire chamber. Also, it has optional equipment that the client can select to meet.

bioburden testingFalse positive results are usually due to laboratory contamination due to the technician/technique’s test or error environment, and generate additional work regarding additional documentation required, and add significant cost as it delays or prevents the release of a product for its sale. The Telstar sterility insulator has been developed to cover a wide variety of customer needs. The ability of the units to provide a reliable aseptic environment for testing for sterility and other aseptic processes is unquestionable.

A minimum reduction of 6 logarithms in microorganisms of spore formation is achieved and validated consistently with a challenge test of biological indicators. The range of Telstar sterility test isolation equipment is suitable for sterility testing of both direct injection and filter membrane with the flexibility of being able to decontaminate with different types of available decontamination systems.

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barrier isolator hood The first sign of impotence in the couple is having sexual intercourse without using contraception for a year and not getting pregnant. In case this happens, you should go to a fertility specialist to do a series of tests to both members of the couple.

As for female sterility, this usually does not manifest itself in any way, so the woman will not notice any symptoms and will not be aware of the problem until she goes to a gynecological review or consultation for fertility problems. However, sometimes there may be discomfort or signs that make the doctor suspect pathology, such as pain, discomfort, menstrual changes and even fever. In case of any trouble or sign of alteration, a doctor should be consulted, but it is essential that the woman goes to periodic gynecological exams to guarantee her health and well-being.

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