Why Clean and Sterile Manufacturing Matter for Your Cleanroom Apparel

Protecting your controlled environment, your product, and your people is your topmost priority. But how certain are you that your cleanroom apparels are not introducing more contaminants? The truth is that, depending on the process of manufacturing used, it is likely that your cleanroom wears are not free from particles – because something is sterile does not mean that it is completely free from contaminants.

In an aseptic fill-finish, knowing the difference between industrially produced sterile garments and clean manufactured sterile garments is crucial, as this will help you to determine the cleanroom garment that is right for your needs.

At AbbVie, we deal in fill-finish manufacturing. We have successfully advanced and distributed drug products for over 130 years, delivering products to more than 175 countries globally. There is no basis for the question as to whether or not we are excellent at what we do. 

Clean Versus Sterile Cleanroom Clothing

‘Clean and Sterile’ Garment

A ‘clean and sterile’ garment is both clean and sterile manufactured. This means that the garment is constructed and sewn in a controlled, clean manufacturing environment. A clean-production facility ensures the following:

• Every staff is gowned in the class appropriate cleanroom garment

• Each operator is trained in clean manufacturing and good cleanroom hygiene principles.

• Work surfaces are wiped clean and disinfected at predetermined intervals throughout manufacturing.

• Operators do not add any particulates onto garments during the manufacturing and construction process.

On completing the manufacturing lot, it undergoes a dose of validated radiation to attain sterilization.

Sterile Cleanroom Garment

A sterile garment can be produced in any type of facility. On completing the garment, it undergoes a process of sterilization. One crucial thing to consider is that sterile cleanroom garments are not often clean-processed. Due to this, the garments possess a heavy load of particles on the surface. And this can add foreign particles to your controlled environment.

Feel Free to Ask About the Process of Manufacturing

Suppose safety is your priority – like it should – do not be scared of asking for the data behind the cleanroom garments you buy. Cleanrooms are classified by the ISO (International Standard Organization) according to the size and number of particles allowed per volume of air.

Ask questions such as the following:

• What kind of sterilization process do the garments undergo?

• To reduce excursions, how are the garments packaged?

• Are the cleanroom garments clean-manufactured?

• What is the International Standard Organization classification of your present cleanroom garment manufacturing facility?

If you can, we recommend that you insist on clean-produced garments. The manufacturer of your garment should do everything possible to reduce the risk of contamination of foreign particle, and it begins with a process of clean manufacturing.

At AbbVie, the nature of your biologic drug notwithstanding, you can count on us when it comes to fill-finish manufacturing. We will provide reliable, safe, and ready to use products. To learn more about how we can assist you with aseptic fill-finish, contact us now.