A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals so as to ensure the quality of the products produced is not only achieved but also maintained. In order to achieve such a sterile environment, the products, as well as clothing that enter the GMP clean room, should be of the highest quality to prevent bringing in any contaminants from other places.
Therefore, when selecting the cleanroom garments, the quality of the garment, as well as its cost, should be the key considerations. Employees also need a flexible garment that will not prevent them to work effectively in the cleanroom. The following factors need to be considered when choosing the right garment for the
cleanroom in the pharmaceutical industry.
The Class of the Cleanroom
The class of the cleanroom is one of the important factors that must be considered when choosing the garment for the cleanroom. Those cleanrooms that are of higher cleanliness always require a garment that covers the entire body to minimize the
chances of contamination in the cleanroom. For example, employees working in the ISO class 5 cleanrooms need to wear not only the coveralls but also hoods and boots as well as masks and gloves.
Type of Cleanroom
The type of cleanroom should also be a factor to consider when choosing
sterile area clothing for pharmaceuticals. In a cleanroom that produces sensitive products such as vaccines under a sterile condition, employees should wear a garment whose fabric is resistant to multiple cycles when sterilizing the manufacturing garments.
Static Charge
Since a cleanroom is supposed to be sterile and free from other contaminants at all times, static electricity is very crucial when it comes to how to choose cleanroom clothing. When an individual wears a garment that has a higher
static electricity, contaminants such as bacteria can get attracted to the garment through static electricity which in turn will contaminate the cleanroom. Therefore, a garment for cleanroom should be manufactured from a material that is static dissipative with a resistance range of 106-108 Ohms.
Garment Changes
There are different types of cleanrooms with different
standard operating procedures. For example, some cleanrooms require that employees change their garments per week whereas others only require using the same garment for quite some time. Therefore, cleanrooms that require a change of 20 garments per week should choose reusable launderable garments.
Compatibility
When choosing the garment for the cleanroom in pharmaceuticals, then you should choose a garment that is compatible with other accessories such as gloves and masks as well as footwear.
Visitors
The number of visitors that visit the GMP clean room on a daily basis should also be a key factor to consider when it comes to how to choose cleanroom clothing. If the cleanroom gets many visitors on a daily basis, then you should go for the launderable garments. And if the cleanroom receives few visitors, it will be better to choose the disposable garments since it will be economical. You may choose disposable garments for visitors and reusable or washable garments for the employees.
Good Information
ReplyDeleteIs there a criteria/standard for selection of clean Room garments in ISO 8 class clean rooms for oral dosage form?
ReplyDeleteThanks.
Eric Chang
Good article, Thanks for sharing...
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