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GMP Annex 1 is updated: are you compliant?

Annex 1 of the revised GMP: deadline of 25 August 2023 for compliance

After several years of work, Annex 1 of the GMP (Manufacturing of Sterile Products) has been updated. What is it? Who will be impacted? What changes will be required and how can we help you? You can find all the answers below.

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Which cleanroom wipes to use in your controlled environment?

Cleanroom Kangaroo Coverall

Our Kangaroo cleanroom garments incorporate a design solution that eradicates the need for single use plastics . This innovative solution, an integrated pouch, maintains contamination controls by providing an additional barrier to your critical environment. The innovative curved zipper allows for easy access and unfolding while removing the need for plastic packaging. Kangaroo garments are comfortable, made of lightweight material and can provide an annual saving of 4kgs of plastic waste per operator. Garments available include tunics, under garment tunics and undergarment trousers. View more about this product here - https://youtu.be/9gpJayeYYsc

Cleanroom Micronswep Cleaning System

The time and cost-saving lightweight MicronSwep™ cleaning system removes the need for water, wringers and trolleys in cleanrooms as the mops are pre-dosed outside the cleanroom. The system accumulates particles, cleans and dries – all at the same time. Special microfibres on the mop surface ensure that particles are not only removed from the surface being cleaned but are captured within the mop. A single 35cm mop can cover 15m2 and a 50cm mop can cover 20m2 surface.

Cleanroom Flexi Mat

Our high-performance Cleanroom Flexi Mat system prevents up to 99.9% of foot and airborne contaminants from entering or exiting your critical control points. The high surface energy attracts, collects and retains contaminants, including metal particles between daily cleaning. This ensures that contamination from feet and wheels to your cleanroom or controlled environment is minimised. ​

Cleanroom Clearcrown Goggles

Particulate contamination can go both ways. Therefore, it is important to protect both the operator from harmful substances used in production and the batteries from human contamination. Our Clearcrown goggles are PPE certified and guarantee at least 2 hours of quality work without condensation. They accommodate prescription glasses and fit snugly around the face contours.

Cleanroom Undergarments

With contamination control as the primary consideration in every cleanroom, undergarments provide an additional layer of control or double barrier effect. Undergarments can be rented in a variety of lengths to ensure the comfort of the wearer. The fabric is lightweight and breathable and primarily worn under coveralls, but they may also be worn as a single layer with a cleanroom coat to set higher hygiene standards in non-sterile or controlled areas.​

Cleanroom ESD Garments

Our 100% metal-free ESD certified coverall and overboots are approved for ISO class 5 (GMP grade A/B cleanrooms. Its liquid and powder repelling C6 finish protects the wearer from microscopic particles (graphite, etc.) penetrating the garment. Our expert knowledge of the ESD challenges and validated decontamination processes ensure your staff is equipped with the right garment solution for battery production. The solution consists of cleanroom coveralls and boots for complete protection.