Quality Assurance

For over half a century, CleanRoom Garments has been at the forefront of delivering outstanding services in contamination and infection control solutions, maintaining our continued leadership in this specialised field.

Our enduring commitment to delivering exceptional contamination and infection control solutions, tailored to the evolving needs of critical industries, has been the cornerstone of our success. Backed by a team of experienced professionals, including scientists with industry backgrounds, we have continuously pushed the boundaries of technical excellence and embraced the latest advancements in clean room technology.

9001 : 2015

AS/NZS ISO 9001: 2015 Quality Management Systems

14644-2 : 2015

All CRG’s garments comply with AS/NZS ISO 14644.2-2015

17025

NATA certified laboratory in accordance with ISO 17025

Assurance of product quality factors include:

We offer you the flexibility to choose the garment type and fabric that suits your Cleanroom application. We pay attention and control each step of the process to ensure a high quality outcome every time.

Explore our products

Selection of quality parts and materials

Adequate product and process design

Control of the process from start to finish

In-process and end-product testing.

Environmental testing

At CRG, we perform regular tests to make sure your garments/products are truly ready for use the moment they leave our doors. The following is a list of regular tests CRG carries out to ensure you receive the highest quality of service and products.

Garment particles & fibres

Garments are tested for particle and fibre contamination using test methods AS 1807.9 (1989) and 1807.19 (1989). Garments tested are randomly selected, this method requires garments to be vacuumed in predetermined areas and the air to be passed through a membrane filter. The filter is then counted microscopically and the result calculated to assess garment class. Refer IEST RP CC 003.3

Bioburden: Garments processed by CRG are monitored weekly in all machines for bioburden contamination. The methods used for processing and recording will include the use of contact plates applied directly onto the processed garments. These samples are assessed for bioburden level and expressed in Colony Forming Units (CFU). Counts are assessed against limits defined in PIC/S Code of GMP Annex 1.

Water particles CRG LQM 116

Garment processing water is monitored on a daily basis for particulate contamination. Samples are taken from “point of use” for all processing areas. 2um and 5um sizes are monitored.

Bioburden: Garment processing water is monitored weekly for microbial contamination. Filtered feed water samples are assessed for bioburden level and expressed in Colony Forming Units (CFU).

Air particles

Daily sampling is conducted in real time to verify ongoing compliance with CRGs Certified Grade B Cleanroom classification. All counts are assessed against EU GMP / ISO 14644.1.

Bioburden: Cleanroom air is monitored on a monthly basis. Samples are assessed for bioburden level and expressed in Colony Forming Units (CFU). Counts are assessed against limits defined in PIC/S Code of GMP Annex 1.

Surfaces

Cleanroom Surfaces are monitored on a monthly basis. Samples are assessed for bioburden level and expressed in Colony Forming Units (CFU). Counts are assessed against limits defined in PIC/S Code of GMP Annex 1.

Personnel

Cleanroom Operators are monitored on a monthly basis. Samples are assessed for bioburden level and expressed in Colony Forming Units (CFU). Counts are assessed against limits defined in PIC/S Code of GMP Annex 1.

Keep track of all your garments!

CRG Barcode all garments and mops going through our cleanroom processing facilities. This provides CRG and clients with the ability to track where their garments are and how many times they have been returned to CRG for washing and/or sterilisation. This information is then stored on CRG’s database and can be accessed by a customer’s Key Account Manager.

Clean Room Garments also uses identity chips in our garments and mops. This removes the risk of the barcode being damaged or unreadable. The chips are sewn into the barcode so there will been no change in comfort or quality standards of the garment or mop.

Our quality brand partners