FAQ Quality Service Vendor

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Quality

  • 40 years of excellence in contamination/infection control solutions
  • CRG continues to lead the market in this field. This is due to our ability to exceed quality standards and our consideration to our customers high standards and requirements
  • We have developed several systems to meet your needs and exceed our customers’ expectations
  • CRG is compliant with the requirements of AS/NZS ISO 9001:2008 Quality Management Systems
  • The Clean Room is compliant to the PIC/s Guide to Good Manufacturing Practise for Medicinal Products
  • Sterilisation processes are validated by NATA accredited laboratories
  • All garments manufactured and processed by CRG, comply with AS/NZS ISO 14644.5:2006
  • The non-sterile garments processed at CRG have low bio burden levels
  • CRG also offers you the flexibility to choose the garment type and fabric that suits your Cleanroom application best. We can rent you suitable garments, launder your own garments or provide a combination of the two that suits your business. We will clean any suitable cleanroom compatible garments.
  • Assurance of product quality is derived from attention to a number of factors including selection of quality parts and materials, adequate product and process design, control of the process, and in-process and end-product testing.
  • All CRG operators in processing and service are given practical and written training on GMP compliance. Process operators are given regular training on designated work instructions relating to their job function. Annual training on critical tasks such as cleanroom gowning and cleaning is provided to all production staff.

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.

GARMENTS –Particles and Fibres

Garments are tested for particle and fibre contamination using test methods AS 1807.9 and 1807.19. Garments tested are randomly selected (a minimum of 2 garments per machine per week).

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 003.4

GARMENTS – 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 of the bioburden level for Total Viable Count (TVC).

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. 2mm and 5mm sizes are monitored.

Water - Bioburden

Garment processing water is monitored weekly for microbial contamination.

Samples are taken from “point of use” for all processing areas and analysed using methods: LQM 131

Airborne - Particles

To monitor compliance to annual Cleanroom certification, testing is done in real time on a daily basis in predetermined locations to ensure all critical areas are monitored. All counts are averaged and converted to (count/m3) then assessed to an ISO classification.

Airborne - Bioburden

Critical process areas are monitored on a monthly basis using an Airdeal bioMérieux air sampler. Air samples from predetermined locations are transferred onto agar plates.

Surface - Bioburden

Critical processing surfaces are monitored for bioburden levels on a monthly basis using contact plates.

Operators – Bioburden

In order to assess gowning effectiveness, cleanroom operators are monitored monthly at end of shift for bioburden levels, using contact plates on their gloves, sleeves and the front of their coveralls.

Quarterly Environmental Reports are available on request.

Barcoding and Chipping

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.