A good condition of the facilities, apart from being part of the GMP guidelines, will offer greater confidence in its compliance and will reduce the risk of audit observations due to the poor appearance of the installation.
Robust, reproducible, and validated cleaning and disinfection protocols using new, safe, reliable and environmentally friendly technologies and methods to clean up corrosion and roughing from cleanrooms and stainless steel processing equipment.
The appearance of accumulated residues is that of stains on stainless steel surfaces that, if not removed, will eventually cause rouging and corrosion. Residues can also be present in the glass of clean room windows and doors, usually showing white or yellowish water marks.
They are a consequence of the repeated application of disinfectants. Current cleaning and disinfection SOPs call for the routine application of chloride containing disinfectants on cleanroom surfaces. The build up of disinfectant residues is the major cause of rust and rouge on stainless surfaces and equipment in GMP cleanrooms. The sporicidal agents leave the heaviest residue and therefore have a more corrosive effect.
Residue build up needs to be removed because it prevents disinfectants from reaching the surfaces to disinfect and acts as a shelter to bio burden build up. We may think that
we are disinfecting, while the disinfectant does not really reach the microorganisms as intended. The subsequent dislodging of residue due to routine mechanical activity like mopping and cleaning, leads to release of the microflora under the residue into the critical area, causing spikes in counts.
Most sites do not distinguish between a cleaning and a disinfecting protocol. It can be compared to brushing of teeth and using a mouthwash. Brushing is the mechanical action that cleans. Using a mouthwash is the disinfecting of the cleaned teeth. Using a mouthwash only, will lead to build up of plaque between the teeth.
Vestilab proposes new methods and technologies that are safe, reliable and environmentally friendly. They alow robust, reproducible and validated cleaning and disinfection protocols to clean corrosion, rouging and residues that affect clean rooms and stainless steel processing equipment. Audit Ready Conditions 365 days a year.
A proactive prevention and remediation of rust and rouging which addresses the problem of the root cause and eliminates the residues of the disinfectants used during the daily or weekly cleaning SOPs will be vital for the health of the equipment.
Vestilab recommeds the use of the Sahara Mop for mechanical action to dislodge residue with WFI coupled with a Sterile Detergent for surfactant action. An sterile detergent is required since most of the residue molecules are insoluble in water alone. They need to be carried away if not dissolved. Surfactant action of the detergent helps in carrying away the insolubles particles. Once cleaned, the surface is completely exposed to the disinfectants, which can achieve the desired contact times and keeps the area under control.
Foamtec's line of Sahara® Remediation are cleanroom grade abrasives designed to quickly remove rust and rouge and polish stainless steel to a 5-10ra surface finish. This allows 304 and 316 grades of stainless steel to self-passivate.