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Big Blue Blog - Cleanroom Decontamination Audits & Special Customer Requirements

Big Blue Blog - Cleanroom Decontamination Audits & Special Customer Requirements BlogCleanroom05.05.2022

Customers for decontaminated products will audit their key cleanroom suppliers, including decontamination facilities, to ensure that the services provided meet the needs of their contamination control systems and regulatory requirements.

The exact format of these audits will depend on the organisation involved but a minimum audit checklist will include the following;

  1. Profile and organisational structure of the clothing and consumables decontamination company.
  2. Cleanroom design, layout, classifications and validation.
  3. Water systems and water specifications.
  4. Product and people flow.
  5. Process controls and monitoring.
  6. Batch records.
  7. Quality Management System (QMS) including accreditations, document control, standard operating procedures, deviation reporting and investigation, change control, validation.
  8. Staff training and training records.
  9. Garment particulate testing and results.
  10. Microbiological monitoring programme and results.
  11. Calibration and records.
  12. Engineering maintenance.
  13. Disaster recovery plans.

When sterile products are required then the sterilisation process will also need to be audited.

Audits are an essential element of contamination control and also provide an excellent forum for the exchange of ideas and information of benefit to both customer and supplier.

Special Customer Requirements

Cleanroom decontaminated garments and consumables are used in a wide variety of manufacturing operations. Each manufacturer will use the principles of contamination control to protect their product but each location and process will have different requirements.

Cleanroom decontamination plants offer a range of standard products which are designed to meet the majority of customer needs, however, if a particular operation requires a unique product or service the cleanroom decontamination plant will be able to work with the customer to develop the best and most cost effective-solution.

Examples of special products and services are;

  1. The cleaning and decontamination of medical device components.
  2. Packing and sterilisation of equipment packs.
  3. Specific impregnants on wipes and mops.
  4. User specific garment design.
  5. Machine and equipment covers.
  6. Unusual fabric requirements.
  7. Additional microbiological or particulate testing.
  8. Special validation exercises.

In addition new fabrics, products and processes are being continuously developed by the cleanroom garment and consumables decontamination industry to match the expanding global use of cleanroom technology.