April 24, 2014
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Understanding the role of sterility testing in compounding
Pharmacy Purchasing & Products
First appearing in the British Pharmacopoeia in 1932, the sterility test included the basic features of the test we use today: Two media, a prescribed dilution scheme, and a defined incubation time. Shortly thereafter, the USP also adopted a sterility test; the first version, which appeared in 1935, included one medium, a dilution scheme and a retest provision to evaluate failures. Perhaps surprisingly, today's sterility test has changed little from its initial origins.
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Evaluating the sterile barrier of complex drug delivery systems
New injection-delivery systems have introduced new challenges to package validation and product development, particularly for container closures. Each component coming in contact with the critical product path must be validated to provide a reliable sterile barrier. Planning for container-closure integrity testing of the delivery system is crucial.
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Safe management of oral chemotherapy drugs
Pharmacy Purchasing & Products
Guidelines for the safe handling of IV-based hazardous drugs are well established in the traditional pharmacy settings of hospitals and infusion clinics. However, the increasing availability of oral chemotherapy formulations means that a greater number and variety of locations are handling these medications than ever before.
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Contamination control using hot air sterilization in carbon dioxide incubators
Microbial contamination poses a major risk in cell culturing and remains undetected for a long time since contamination does not necessarily overgrow the cultivated cells. Subtle changes such as lack of essential nutrients and excretion of microbial metabolites may promote a pH change which ultimately compromises cell proliferation. Mycoplasma infections pose the highest risk and can change host cell morphology or cause chromosomal aberrations. This article compares different contamination control concepts for CO2 incubators from the user's perspective.
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Monitoring and cleaning in the cleanroom
Pharmacy Purchasing & Products
Essentially, a comprehensive environmental monitoring program provides immediate feedback on the state of USP 797 compliance for critical IV preparation. Environmental monitoring can exhibit consistent asepsis within compounded sterile preparations, as well as delineate potential contamination trends, providing the pharmacy with a forecasted opportunity to take action.
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Clean Air Essentials

IsoTech Design is pleased to introduce its new sister company: Clean Air Essentials. The company is focused on consumables used in sterile compounding, chemo compounding, hormone compounding and environmental monitoring and on SOPs for USP 797 compliance.

Check our offers on the Essentials kit, Safety kit and sleeve kit, and ask for our latest standard operating procedures for your clean air environment.

S.O.P Cleaning & disinfecting of the C.A.I & C.A.C.I — Decontamination

IsoTech Design eNews/Infolettre

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