Cleanroom Validations
Cleanroom validations are required not only after a new cleanroom has been built, but also intermittently throughout its life.
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As 2018 comes to a close, Vivid Air would like take a look at the year that has passed and what we have accomplished.
It is our goal to always provide the highest quality equipment along with expert services – ensuring our clients receive only the best.
In 1978, the first in-vitro fertilisation (IVF) baby was born, since then the importance of Assisted Reproductive Technology (ART) has grown as techniques and success rates continue to advance.
All cells, including gametes (sperm and egg) and embryos (bundles of cells), are extremely sensitive to laboratory conditions. Temperature, pressure, the composition of the agent they are handled and grown in, and the quality of air – all play a role in pregnancy success rate.
A cleanroom is a modular environment in which several factors are kept under control, including; relative humidity, temperature, differential pressure, airborne particulates, microbes, and air flow.
Regular cleanroom validations are a vital part of achieving cleanroom compliance prior to operation.
Additionally, further validation is required during operation to ensure that a cleanroom continues to meet its ISO Class parameters.
One of the biggest threats to the sterility of a clean-room is the workers who carry out duties inside it. There is always a risk of contamination due to inadequate and improper gowning procedures. Lab coats, gloves and other personal protective equipment exist to minimise this risk, but without correct gowning procedures, their efficacy is greatly limited.
In this article, we provide a comprehensive breakdown of proper gowning technique, with notes on common problem areas.
The financial consequences of microbial contamination of products in a clean-room can be significant; entire batches of an order may be rejected because of small amounts of contamination. Clean-room workers hold great responsibility, and they need to be aware of what that entails.
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