Media systems – new chapter in Annex 1

Vacuum and cooling systems

One of the new chapters in Annex 1 deals with media systems. In addition to requirements for the design and operation of water systems, vacuum and cooling systems are also listed for the first time. Among other things, the new Annex 1 covers the requirement:

“6.23 There should be periodic cleaning/disinfection for both vacuum and cooling systems.”

Condensation phenomena

My comment: This requirement can be misunderstood. This does not mean, for example, that the piping system of the coolant should be cleaned / disinfected (as the first requests for comments have already been received by gmp-experts), which will be difficult as a purely technical system. Rather, this refers to the areas of installations where condensation can lead to localized and permanent moisture formation and thus the risk of germ formation and even biofilm formation.

Regular checks

What should you do? Regular monitoring means integrating these points into routine hygiene monitoring and regularly cleaning and disinfecting the affected areas, e.g. in the refrigerator, but also in the cooling register of a ventilation system. For the latter, the application of VDI 6022 Sheet 3, for example, would be highly recommended. A very good basis for a suitable hygiene plan is provided here in the form of a directly implementable checklist.

Cleaning / disinfection of vacuum systems

The cleaning / disinfection of vacuum systems primarily refers to all systems that are used to remove loads (heat, vapors, moisture, particles) from the environment of the product / process (generally referred to as source exhaust air systems). These can be classic extraction systems on workbenches, vacuum cleaners or permanently connected central extraction systems on process plants (e.g. vapor extraction systems on washing machines).

Pipes / fittings and filters

In any case, cleaning / disinfection in relation to the corresponding clean room zone in which the system is located includes the removal of all contaminants from pipes / fittings and filters that could return to the process / product in the opposite direction to the suction direction during operation.

Requirement from Annex 1

Conclusion of this new requirement from Annex 1: A corresponding maintenance / cleaning plan and integration into routine monitoring as a GMP routine is the necessary basis for this and should be included in the company’s hygiene system as an important component of the Contamination Control Strategy (CCS).

Dipl. Ing. Wolfgang Rudloff

Vita

• 30 Jahre Erfahrung in der pharamzeutischen Industrie

Expertise:

• Geprüfter Sachverständiger für Reinraumtechnik und GMP-Management
• Lead Auditor und Gutachter

Stationen:

• Technischer Leiter
• COO / Gesamt-Herstellungsleiter
• Remidiation-Manager
• Projektleiter Neubau/GMP-Upgrade
• Management-GMP-Beratung
• Fachautor, GMP-Trainer, Mediator