Integrating Hardware

There are lots of developing technologies and products applicable to cell and gene therapy cleanrooms. Suppliers of hardware, consumables, controls, instrumentation, consumables, cleaning services, contamination control consultants, trainers and others all are involved. This on-going discussion will be focused on how different groups should coordinate for best results. For example, some of the requirements which apply to open systems are being applied to closed systems. The net effect is to reduce the advantage of switching.

One of the newest hardware initiatives is the variable air flow operating mode which controls the flow to various areas of a room. The goal is to keep particle counts within a given range. The advocates believe that the analysis of this information will be helpful in gowning protocols and other aspects related to human activity in an area.

Cleaning surfaces manually is specified based on elapsed time rather than need. What does an effective vaporized hydrogen peroxide disinfectant system do to change the schedule. Note that we have a discussion on integrating VHP.

The potential to alert personnel to exceedances is a function of the rapid reporting of particle counts in a local area. TSI has a new continuous viable particle counter.

1155

TSI

cell and gene

particle monitors

viable particle counter in real time

1149	PMS	cell and gene	particle monitors	monitors and support to meet Annex 1
1120	Met One	cell and gene	instruments	air particle counters are reliable, durable and easy to use

One company which has a unique integrated approach is CWS. They furnish garments, operate laundries, provide cleaning services and provide training for cleanroom personnel. They also have facilities throughout Europe. So, they have local talent to utilize relative to integration benefits. In their coaching program, they first inspect sources such as air locks. So, they would be a good resource to question relative to VHP at air locks.

1156	Ortner	cell and gene	Air lock	Air lock with integrated H202 decontamination
1164	CWS	cell and gene	Training	Start with an analysis of contamination sources

Katrin Hoessler from CWS wrote an article in Cleanroom Technology Jun 2023 about behavior in airlocks such as not sneezing into the crook of the arm and wearing jewelry. She explains the first air effect and the influence of personal hygiene. She addresses mnemonics such as moving slowly and in a controlled manner.

CWS offers cleaning services with 4 different routines. There is the first cleaning. It can be repeated as events occur. Routine cleaning is another option. With special equipment and applications, a specialist team can be employed. With these service options CWS can better organize cleaning in the integrated program.

2004 CWS biopharmaceuticals Cleanroom Cleaning With a wide range of services CWS is your best option for cleaning.

Integration involves services available in a given geographical area. CWS has been acquiring companies for this purpose.

The laundries need to be located near the end user and also to be able to quickly deliver consumables. Cleaning service people have to be a short distance away. The training staff can be at some distance. So, Benelux may be served by the trainers in Germany.

So far, we have examined cleanroom companies such AES Clean and integrated service suppliers such CWS. What about consulting organizations. Can they take the lead, follow or not contribute.

One group who can make a big contribution are niche experts. Mcilvaine uses the same approach as to sales foreasts to identify niches which are small enough that an individual can maintain a leading position?

Barry was formerly VP of Strategy at Merck. In recent years he has been a consultant assisting biopharmaceutical companies from the perspective identifying buyer needs and assisting them in finding the products and services to meet those needs. He believes that Cleanroom suppliers could contribute to integration of the HVAC system with gowning protocols and even selection of cleanroom furniture. He points out where the movement of a table in relationship to the wall made a big difference in flow patterns.

Jan Eudy has spent 30+ years as a cleanroom/contamination control and microbiological subject matter expert.

She is an expert in relating clothing and contamination contribution. For example, relative to single use garments In all cleanroom environments, human sourced contamination is the easiest to control yet humans contribute the most contamination. Disposable, single-use cleanroom compatible, gamma compatible cleanroom garments are recommended for:

• Cleanroom operations that are too small to have a reusable cleanroom garment program

• Start-up cleanroom operations (i.e., universities, research laboratories, etc.)

• Maintenance and cleaning operations that would significantly soil, stain or damage reusable cleanroom garments

This initial compilation will launch a continuing discussion of the ways in which the different specialist companies can work together to better integrate all the products and services. Some companies now offer both cleanrooms and consumables. What role can they play? Companies such as CWS who are integrating training, consumables and cleaning can make contributions. What role does a biopharmaceutical room specialist such as AES play? We talk about entering the age of artificial intelligence, but we already have the measurement and intelligence tools to determine outliers in terms of personnel or products and to provide better contamination protection. So, we encourage you to enter the discussion. Send us your comments.