9 Key Questions To Ask About Class 3 ISO Cytotoxic Isolators

as originally published on Faster Air S.R.L.

It is an absolute given that any Class 3 ISO cytotoxic isolator must be safe: it must protect the operator and the material being analysed.

In a wide range of operations (QC testing, sampling and dispensing, vessel charging and offloading, milling), cytotoxic isolators must safeguard the:

 

• operator and the environment from any contamination hazards from the material
• material being manipulated from any possible contamination from the environment.

But that does not mean all Class 3 isolators are made equal. Significant differences – smart design and attention to detail – separate the best in class from their basic counterparts.

Never forget that isolators have human operators. Their comfort when working is an important factor in underpinning safety and security. There is also the small matter of cost…

No-one specifying equipment as important as a cytotoxic isolator would skimp on quality where safety is concerned. But no organisation’s budget is without its pressures. Few if any specifiers are ever given carte blanche or a blank cheque.

And allied to budget is the ever-important matter of carbon footprints. So any class 3 isolator’s energy consumption and operating costs should be as low as possible – without compromising safety in any way.

These are the crucial questions you should ask when specifying an isolator…

1. Is The Laminar Air Flow Always At The Perfect Level?

Working with chemotherapy drugs means working with sterile/injectable products. So constant laminar air flow is a key factor.

Does the isolator deliver the best possible laminar flow performance? Not just at commissioning or during preventive maintenance – but consistently (even with the progressive normal clogging of HEPA filters).

Does the isolator have a 7° sloped front AND back to ensure true laminar airflow in the work chamber?

2. Will Your Isolator Allow You To Run Leak Tests Yourself?

Safety is critical. And the price of safety is eternal vigilance bordering on paranoia. So you need an isolator with an automatic ATV valve that allows you to run leak tests yourself – whenever you want, every day.

No need to wait for preventive maintenance, no special tools, no ladder: just a few clicks on a soft-touch keyboard.

3. How Safe And Easy Is It To Change The Main Filters?

Can you remove the main filters and bag them directly in the working chamber (avoiding the need to bring contamination outside)? Can you take them out only when they are completely sealed and safe? Can they be passed through the side hatch (rather than having to open the front visor)?

4. How Many Fans Does The Isolator Have?

Safety should always come first. Regardless of whether the isolator is ducted or recirculating, is it fitted with two EC fans as standard? (One for downflow, the other for exhaust.)

5. How Good Are The Construction Materials?

Are the front window and outer hatch doors manufactured from stratified 8 mm safety glass for superior resistance to cleaning detergent? Skimp on the glass quality and you could discover that the surface becomes damaged over time due to repeated cleaning.

The work surface in the main chamber and the sliding hatch trays should be manufactured from stainless steel 316 for the best pharmaceutical-grade finishing possible.

AISI 316 stainless steel has improved corrosion resistance thanks to the addition of molybdenum to the alloy: 316L has less carbon – enhancing its anti-corrosion performance still further.

AISI 316 and 316L are Austenitic stainless steels; they are non-magnetic so they will not interfere with sensitive instrumentation.

6. Is The Isolator Truly ‘Clean Room Friendly’?

Isolators are designed to be installed in clean areas where:

• a dust-free environment is vital
• attention to cleanliness is at the highest levels.

Has the isolator been designed to have the smoothest surface possible for easy and effective cleaning? Did the designers minimise the use of bolts, latches and screws to enable extensive cleaning of the isolator inside and out?

7. How Comfortable Is The Isolator To Use?

Your scientists could be spending eight hours a day at their isolators. And equipment that is awkward or uncomfortable to use increases the likelihood of mistakes.

At best, your staff will be unhappy and less productive; at worst you risk errors that could damage specimens, void experiments, delay projects (costing time and money) and even result in safety protocol breaches or accidents.

Does the isolator leave enough space (480 mm) for the operator’s knees? Can LED lighting levels be adjusted to suit different operators?

Are the glove ports big enough (Ø300 mm) to be comfortable during operation and cleaning?

Is the isolator quiet enough? (Not exceeding 55dBA – the same level as a quiet conversation, an electric toothbrush or a coffee machine.)

8. How Low Is The Isolator’s Carbon Footprint?

Does the isolator have technical features that reduce energy usage and your carbon footprint? Look for features such as electronically commutated (EC) blowers, an ECS microprocessor, dimmable LED lights and low-pressure drop filters?

Your customers will be looking to you as a supplier to help them reduce their carbon footprint. A prime example is the NHS Carbon Footprint Plus target (which includes the health service’s wider supply chain).

9. What Optional Extras Are Available?

Can you specify options such as a back wall cut-out for an LCD screen? Touchscreen control? An isokinetic head for continuous particle counting?

Other important options include:

• CCTV for safety and compliance
• exhaust charcoal filters
• electrically adjustable height
• intercom control by foot switch
• automatic electric inner doors
• customisations on request.

Faster Air GloveFAST Cyto Pharma Class 3 Isolators

GloveFAST Cyto Pharma Class 3 ISO/FDIS 14644-7 negative pressure isolators have a vertical laminar airflow and physical separation between operator and product (gloves). Dusted, filtered and sterile air passing through the main H14 HEPA/ULPA filter ensures optimum laminar airflow on the working surface.

These isolators are available in three standard configurations (in either epoxy-painted steel or stainless steel): 2 (pass box) 4 (feet) 2 (gloves), 2-5-2 and 2-6-4.

Get Expert Technical Advice

For more information on Class 3 ISO cytotoxic isolators click HERE to contact us