An essential detail: cleanroom mop

Pure products can only be created in a pure production site. Successful cleaning and disinfection of cleanrooms is characterised by effectiveness, process reliability, user-friendliness and economic viability.

The overriding goal: cleaning and decontamination processes should restore the desired purity condition of a surface (VDI 2083, page 4.4). The cleaning of cleanrooms requires the utmost care, down to the smallest detail – even with regard to cleaning utensils. Conventional mop covers and handles endanger production as they become a particle source themselves. Only cleaning materials designated as compliant ensure the purity of the cleanroom, since they have to fulfil numerous requirements with regard to their material, design and workmanship. After each use, they must be decontaminated and, if necessary, sterilised. In addition, skilled personnel must be familiar with the correct usage of the cleaning materials and have mastered these reliably.

Specific requirements exist for different production processes, these are defined by the respective regulations for the individual purity classes (ISO and GMP):

Requirements
Cleanroom compatibility
  • Containers and materials that can easily release fibres should not be used in pure areas (EU-GMP, Annex 1, sentence 75)
  • All materials, portable and wheeled devices must be appropriate to the purity of the cleanroom and must not interfere with the product and process during their use... (ISO 14644-5, clause 4.5.1)
Design and workmanship
  • Surfaces and moving parts should spread and produce as little contamination as possible...They should have properties that keep creation of contamination by abrasion and chip formation to a strict minimum... (ISO 14644-5, E, paragraph E2.1)
  • The chemical compatibility of all materials used must be considered alongside the operational requirements of the facility ... (ISO 14644-5, E, E1.1)
Fulfilled by:
  • Professional consultation and selecting of suitable cleaning textiles – for example, wiping cloths and mop covers
Requirements
Process reliability
  • Procedures are to be established to ensure that materials and portable and wheeled devices introduced into the cleanroom are not contaminated... (ISO 14644-5, clause 4.5.2)
Fulfilled by:
  • Decontamination and, if necessary, sterilisation, according to cleanroom standards (certified infrastructure: cleanrooms, high-purity media, monitoring systems)
  • Continuous monitoring of decontamination and sterilisation results
  • Electronic inventory management for seamless transparency and safety
Requirements
Cleaning capability
  • All materials should be suitable for effective and frequent cleaning and disinfection ... (ISO 14644-5, E, paragraph E1.2)
Autoclavability
  • Components, containers, equipment and other items needed in a clean area where aseptic work is done should be sterilised... (EU.GMP-RL, Annex 1, sentence 81)
Fulfilled by:
  • Durable and cleanroom-compatible wipes and mop covers
  • Professional processing - decontamination and, if necessary, sterilisation (certified infrastructure: cleanrooms, high-purity media, monitoring systems)
Requirements
Employee training
  • Individuals should be named responsible for cleaning activities; these must be trained specifically for this task... (ISO 14644-5, sentence 4.6.2)
Autoclavability
  • A documentation system must be maintained in order to demonstrate that all staff members have received training appropriate to their tasks... (ISO 14644-5, sentence 4.1.4)
Fulfilled by:
  • Certified staff training on a regular basis (naturally with the corresponding documentation)

These implementations give you a first impression of how carefully a cleanroom cleaning system must be put together. We’d be happy to do this for you: simply contact us.

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