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Kimtech A5 Contamination Control Bundle

Minimise contamination risk in your cleanroom and adhere to EU GMP Annex 1.

 

What to Consider Before Selecting Cleanroom Apparel?

Understand the Advantages of Single-Use Garments

Sterile single-use garments, such as Kimtech™ A5 Apparel, are engineered to reduce contamination risk and offer significantly higher bacterial filtration efficiency (BFE) ratings and particle filtration efficiency (PFE) ratings.

Look for Sterility and Packaging Integrity

Kimtech™ A5 Sterile Cleanroom Apparel is the only solution on the market that is vacuum-packed. This not only ensures the sterility of the apparel but also acts as a visual sterility breach indicator, so you can be assured that Kimtech™ A5 Apparel is sterile when you use it.

Select Apparel that is Appropriate for the Process

Proprietary CLEAN-DON™ technology makes it easy to adopt proper gowning procedures and minimises the risk of contamination during the donning process.

Applicable Solutions

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Head-to-Toe Bundle

The Kimtech™ cleanroom gowning system is designed to provide protection for the head, body, hands, and feet.

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1. Protecting the Head

The Kimtech™ A5 Sterile IHAM, Sterile Hood, and Sterile Face Masks are made from high performance low linting and breathable SMS fabric, designed to simplify aseptic gowning and reduce contamination risk.

2. Protecting the Body and Legs

The Kimtech™ A5 Sterile Cleanroom Coverall's aseptic gowning technique saves time while reducing the risk of contamination. The coveralls are suitable for use in EU GMP ISO 5 Grade A sterile cleanrooms.

3. Protecting the Hands and Arms

Kimtech™ Sterile Cleanroom Gloves are PPE Category III certified and suitable for a range of sterile cleanroom applications. The gloves are hand-specific and made from nitrile, resulting in improved contamination control that meets a range of stringent regulatory conditions. The integrated thumb loop on Kimtech™ Sterile Sleeves keeps the sleeve from rolling back and exposing the arm or wrist.

4. Protecting the Feet

The Kimtech™ A5 Sterile Overboots improve worker safety and comfort, while maintaining cleanliness, providing seamless protection when and where it counts.

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Related Documentation

Kimtech™ A5 Sterile Cleanroom Hoods

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Kimtech™ A5 Sterile Overboots

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Kimtech™ A5 Sterile Sleeves

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Kimtech™ A5 Sterile Cleanroom Apparel

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FAQ

The final revision of the EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was published by the European Commission on 22nd August 2022. Annex 1 is coming into operation in August 2023.

Kimtech™ A5 Apparel is uniquely configured with inside-out folding and built-in snaps that automatically release as the garment is put on, lowering the risk of it touching the floor. A blue line indicator along the inside of the garment guides the operator throughout the donning process and helps them avoid touching the outside of the garment.

Ideal body conditions and comfort are dependent on the base construction material. Kimtech™ A5 Apparel features a spunbond/meltblown/spunbond (SMS) fabric that provides strength, cloth-like comfort, and a strong barrier against both fine particles and bacteria. It also maximises airflow to keep the wearer cool and comfortable.

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Kimtech™ A5 Sterile Cleanroom Coveralls

Sterile cleanroom coveralls featuring innovative Clean-Don™ technology for simpler aseptic donning.

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