Beyond housekeeping equipment, how are FM processes and practices in clean rooms unique? Tarun Ramrakhiani, CEO, SMS Integrated Facility Services, gives us the lowdown.
The KPIs that we cover with our pharma clients for housekeeping are behavioural and procedural. Behavioural KPIs include personal hygiene, grooming, no jewelry policies, basic etiquette at work and of course, hand hygiene technique.
Procedural KPIs include gowning and de-gowning (for both non-sterile clean room as well as sterile clean room), production area regulations (e.g. any equipment or cleaning tools used in production area are not to be used in any other areas), cleaning chemicals used, fibres used, colour-coded cleaning equipment and tools, special procedures for dry mopping, dry vacuuming, wet mopping, glass cleaning, disinfection, washroom cleaning and sanitisation, floor scrubbing and liquid management system.
Colour coding and extensive labeling needs to be done of all equipment to prevent cross-contamination risks. This along with strict control on use of accessories such as mops, cloths and brushes needs to be enforced as these need to be disposed of once their usage span has been achieved as per the area SOP.
Frequency of cleaning
This needs to be clearly defined for each process and area as it will determine the number of people required to service the area. It may vary from:
- Once a day or at the shift changeover
- Product changeover to prevent cross contamination
- Batch changeover as per BMR requirement
- After any ad-hoc or scheduled maintenance
- Repeated cleaning due to any observation from QA/QC/User
With bioburden control, as a singular goal in aseptic processing to ensure safety of any sterile product, the main aim is to minimise human contamination potential, as personnel are the source of primary risk in clean rooms. Unless appropriately controlled, bioburden may contaminate or proliferate to an extent which will compromise the product quality.
We provide a unique Smart Access Control System (SACS) which controls and monitors the number of personnel entering and exiting clean rooms as per the firm’s SOP. This includes limiting access to permitted number of people while identifying the purpose of each entry; operation through a 21 CFR Part 11 compliant system.
We maintain all cleaning records as per the pharmaceutical Good Documentation Practices (GDP). Along with the day-to-day support for validation activities, we have also proposed a Manufacturing Compliance Console to clients which is a touch-based Intervention Recording System which will eliminate the practice of capturing any process interventions manually in the BMR. Instead, this tech offers an interface to integrate all interventions in the BMR electronically.