White Paper: Top 10 Reasons to Use Rigid Wall Isolators

These days several Pharmaceutical companies are moving to single use, flexible film

isolators for containment of potent compounds during Pharmaceutical processing. Flexible

film isolators have also been used for aseptic processes, like sterility testing. These

isolators are a low cost, simple design generally consisting of a stainless steel lower

framework which supports a work table and an upper stainless steel framework that

supports the flexible enclosure. Typical enclosure material can be polyvinylchloride or

polyurethane. The glove sleeves are often made of the same materials and are part of the

enclosure. Air passes through inlet and outlet filters. Blowers can be included to create

positive or negative air pressure and ports or panels added for introducing or removing

items to or from the isolator. These isolators are lightweight, easy to set up, have good

visibility and good flexibility while working in the gloves.

In contrast is the rigid wall isolator. These isolators also employ a stainless steel frame but

their enclosure is generally 316L stainless steel with laminated safety glass viewing window.

Glove ports are mounted on the window where glove sleeves are mounted. Glove sleeve

material can be hypalon, neoprene or butyl. Inlet and outlet HEPA filters with positive or
negative blowers, utility panels and ports for introducing or removing items to or from the

isolator are also provided. These isolators are more expensive than flexible isolators.

However, there are many advantages to using a rigid wall isolator.

When working with highly potent compounds and cytotoxic products, rigid wall isolators

provide an extremely safe working environment for operators. Rigid wall isolators have

been used where nanogram/cubic meter level Operator Exposure Limits have been required.

The HEPA filters can be safe changed from inside the isolator and the isolator can be

cleaned with certain harsh chemicals to neutralize the highly potent compound. Spray

wands and spray balls can be added to the isolator providing a repeatable cleaning method.

Flexible film isolators will not resist harsh chemicals and turn yellow over time with IPA

cleaning. Flexible film isolators require much care when handling sharp materials in and

around the enclosure, as they are subject to puncture. These isolators should be leak

tested frequently to ensure their integrity. The leak test process is slow, as there is much

surface area to test. On the other hand, rigid wall isolators are more robust. Only gloves

and gasketed areas require leak testing. Glove leak detectors are available which can find a

hole the size of a 25 gauge needle in a glove in about 8 minutes.

Gloves and sleeves can be change in situ on a rigid wall isolator without breaking

containment. If a flexible enclosure or its gloves or sleeves have a hole or tear, patch kits

are available. Eventually, the entire enclosure must be replaced. This eventuality needs to
be planned, so not to delay the operation being performed. A spare enclosure should

always be kept in supply. Depending on how often a process takes place, single use

enclosures may need to be changed quite often. The design of these enclosures must be

such that when the enclosure is taken down, it is thoroughly cleaned then completely sealed

so not to expose the operator.

At times, isolator environments need to control relative humidity, have uni-directional

airflow or even have an inert atmosphere. Multiple straight walls lend itself nicely to uni-

directional airflow. Rigid wall isolators virtually eliminate permeation through the enclosure

so a specific environment can be more easily maintained. This is also true when

decontaminating the isolator for aseptic processes. Since there is no absorption into or

permeation through the stainless steel and glass enclosure, chemical decontamination with

hydrogen peroxide vapor or gas results in a faster overall cycle time than is seen with

flexible enclosures. Flexible wall enclosures will absorb hydrogen peroxide to a much

greater extent than a rigid wall stainless steel and glass isolator. The enclosure will release

the hydrogen peroxide gas during the aeration phase, which delays cycle completion. The

isolator interior is generally aerated to 1ppm of hydrogen peroxide.

Today, some standard pre-engineered rigid isolators whose costs are approaching those of a

flexible isolators are available.

 Clean Air Barrier Isolator (CAB)

In summary, the top 10 reasons to use a rigid wall isolator are:

10. Receptive to uni-directional airflow requirement.

9. Ability to safe change filters inside the enclosure.

8. Gloves and sleeves can be changed in-situ.

7. Receptive to special environments without permeation through enclosure.

6. No need to change the enclosure.

5. Approximately 50% faster decontamination cycles.

4. Easy to leak test.

3. Robust, puncture proof enclosure.

2. Resistant to strong cleaning agents and neutralizing agents.

And the number 1 reason for choosing a rigid wall isolator is:

Safely contains Category 4 compounds for increased Operator protection.

Visit our website at www.walkerbarrier.com for more information on our products.