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CRG Quality and Service
Both of CRG facilities are compliant with the requirements of AS/NZS ISO 9001:2000- Quality Management Systems. Additionally, CRG's cleanroom laboratories are NATA accredited, enabling the provision of specialised testing services. All garments manufactured and processed by CRG, comply with AS/NZS ISO 14644.5:2006. 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 monthly training on designated work instructions relating to their job function. This is recorded in training logs managed by departmental supervisors and reviewed by the Quality Department during the annual internal audit process. 6-monthly training on critical tasks such as cleanroom gowning and cleaning is provided to all production staff. Rental and ProcessingThe R&P arrangement is where customers are charged a per week rental charge covering the rental for one week’s garment requirements. For example, if a customer rents 20 garments, they pay rental on 20 garments and 20 x 2 (40) garments are put into the system. Processing is charged as garments are returned for processing. If a garment is not returned, no processing fee has been charged. The rental is charged regardless of whether the garment is returned for processing. Benefits of the Rental SystemThe benefits of the rental system largely outweigh that of the purchase option. Benefits of the rental system include:
Barcoding and ChippingCRG 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. To improve this process, Clean Room Garments is now starting to place identity chips into 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. Quality: Environmental TestingThere are many things to consider when looking for an operator to service your cleanroom materials. At CRG, we take contamination very seriously and run regular tests to make sure your garments/products are truly ready for use the moment they leave our doors. The following a list of regular tests CRG carries out to assure you receive the highest quality of service and products. GARMENTS –Particles and FibresGarments are tested for particle and fibre contamination using test methods AS 1807.9 and 1807.19 for which CRG are NATA accredited. 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 AS 2013.2 GARMENTS – BioburdenGarments 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. Assessment of the bioburden level on these samples is performed by an external laboratory for: Total Viable Count (TVC) and identification of Yeast and Mould. Water-Particles CRG LQM 116Garment 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. (C/R = Cleanroom) Water-BioburdenGarment processing water is monitored monthly for microbial contamination. Samples are taken from “point of use” for all processing areas and sent to an independent laboratory for analysis using methods: AS 4276.3.1:1195 and USP 23. Airborne- ParticlesTo monitor compliance to annual Cleanroom certification, 5 X 1 min air samples are taken using a laser based particle counter. Testing is done at monthly intervals in pre-determined locations to ensure all critical areas are monitored. All counts are averaged and converted to (count/m3) then assessed to an ISO classification. Airborne- BioburdenCritical process areas are monitored on a monthly basis using an RCS Biotest air sampler. Air samples from predetermined locations are transferred onto agar strips for independent analysis. (please refer to Cleanroom maps for sampling locations). Surface- BioburdenCritical processing surfaces are monitored for bioburden levels on a monthly basis using contact plates that are sent to an independent laboratory for analysis. Operators – BioburdenIn order to assess gowning effectiveness, cleanroom operators are monitored monthly for bioburden levels, using contact plates on their gloves, sleeves and the front of their coveralls. Plates are then sent to an independent laboratory for analysis. Site Service ConsiderationsSite Service involves the presence of a CRG Site Service Co-ordinator (on-site at your company) who takes on the responsibility of your garment needs. The Site Service Co-ordinator manages the delivery of garments to your company, arranges garments so they are placed in lockers or shelving systems, removes soiled garments and organises their return to CRG. Key benefits of Site Service Co-ordination include:
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With 40 years of excellence in contamination/infection control solutions, CRG continues to lead the market. This is due to our ability to exceed quality standards and our consideration to our customers high standards and requirements. Taking into account the needs of our clients, we have developed several systems to meet your needs and exceed your expectations: rental and processing, barcoding and chipping, environmental testing, site service, vendor management and many other service considerations.