Top 10 Considerations when Selecting an Isolator Supplier

While price is certainly an important reason for buying any piece of capital equipment, it is
not always the top reason. There are important considerations to examine when selecting
an isolator supplier to be certain that you are getting what you are paying for, before the
purchase order is written.

Supplier Sales Team Experience

Some suppliers Sales team have an engineering background which provides the benefit of
understanding the working and manufacture of an isolator and knowing what questions to
ask the customer of their process so the right isolator solution can be developed. This also
includes experience in integration of isolators and other process equipment. Dialog between
the customer and a technical sales person often results in a better understanding by both
parties and a better design.

Materials of Construction

Not all isolators are created equal. Some are made from flexible materials, other from rigid
plastic material and still others from stainless steel. Stainless steel has a distinct advantage
over plastics as it is more resistant to process chemicals, cleaning agents and
decontamination agents. However not all stainless steel isolators are alike. Some use
polycarbonate window while others use laminated safety glass. Some use PVC piping and
valves while others use stainless steel. Some of the stainless steel enclosures are made of
heavier 7 gauge materials while others are of a thinner gauge. Thin gauge may result in
warping when being welded. This of course assumes the isolator is fully welded and not
simply bolted together. There are many other differences in materials of construction that
will not be discussed at this time.

Controls

Control systems are the brains of the isolator, allowing it to perform as required. Simple
selector switch, single loop controls may be sufficient for the application. Today’s processes
are putting more demand on what an isolator should do. Choosing an isolator supplier who
has experience with inert environments, humidity control, oxygen control, explosion proof
materials, interfacing with decontamination generators and process equipment, operating in
positive pressure and/or negative pressure, uni-directional airflow is very important. This
list requires a Programmable Logic Controller (PLC) to successfully operate the isolator. An
isolator supplier who has experience with PLC systems like Allen Bradley or Siemens is a
benefit, as is one who is a UL (Underwriters Laboratory) certified panel builder or has CE
experience.
Location of the Factory Acceptance Test

There are isolator suppliers all over the world. Performing a Factory Acceptance Test (FAT)
on an isolator system can take several days or even weeks depending on the complexity.
The cost of travelling to the FAT site needs to be considered. Airfare, hotel, rental car and
meal costs vary when considering a supplier in your own country to one thousands of miles
away. Time change is another consideration. During the design and fabrication stage a 6
hour time difference between your site and the suppliers may make it difficult to schedule
Webex meetings or even simple conference calls. At FAT, 2 full days of travel will be
needed when travelling overseas from the USA for example. Arriving a day before the FAT
start may be needed to adapt to the new time zone. These costs and considerations should
be added to the isolator cost when making a supplier selection.

Operator Safety

A well-defined process will help the isolator supplier offer the best design to protect the
operator. Knowing that the operator will be handling highly potent compounds and that the
isolator needs to be cleaned with aggressive cleaning agents should result in the correct
materials of construction and transfer devices. For example, a flexible wall isolator with
simple airlocks for moving materials in and out of the isolator is the lowest price point, but
not the safest solution.

Product Safety

Aseptic products need a positive pressure isolator that can be decontaminated with chemical
agents to reduce the bioburden within the isolator to a six log reduction. Again, choosing
the right materials of construction is important as is handling systems like gloves ports and
half-suits. Certain materials take much longer to decontaminate than others and the
decontaminating agent must be delivered into all areas of the isolator. This often takes
additional fans. Interfacing the isolator with a large autoclave or lyophilizer may require a
more expensive half-suit system so that the operator can effectively access the autoclave or
lyophilizer and not drop what they are handling. Regardless, the gloves are the weak point
of any system and should be inspected regularly. Ask your isolator supplier if they have a
glove leak tester.

Quality of Construction

Is the isolator constructed of heavier 7 gauge stainless steel? Is the inside corners made
with a radius of 5/8” for ease of cleaning? Is caulk used anywhere inside the isolator? Is
the construction welded with all welds polished to <22 Ra surface finish or is the isolator
bolted together? Is the isolator frame painted or stainless steel? These differences will
affect the isolator cost. It is important to see the suppliers work either at an installation or
by making a factory visit prior to purchase.

Ergonomics

Ergonomics, as well as trouble free interfacing with other process equipment is critical. No
one wants an isolator that cannot be readily attached to other process equipment or used
properly by all operators. A supplier that has 3D modeling capability can help identify
potential interfacing issues and look at ergonomic concerns. Then a mock up should be
built and tested by the operators so that the process can be tested and the design refined
before approval to fabricate is given.
Documentation

Vast amounts of documentation are often needed with any equipment. It is not always
enough to just provide an Operation and Maintenance Manual with the isolator. Today, a
supplier should be able to provide:

Functional Requirement Specifications (FRS)

 Detailed Equipment Description
 System Operation
 Modes of Operation (function matrix)
 Alarms & Interlocking

Hardware Design Specification (HDS)
 Components
 Digital and Analog I/O
 Environment (RH, Temp, Nitrogen, etc)

Software Design Specification (SDS)
 Module and Mode Descriptions
 Production, Clean, Pressure Decay

Document Supplier Index

FAT Protocols & Execution

Equipment installation and operator training

SAT (Site Acceptance Test) Protocols & Execution

IQ/OQ/PQ Protocols

Additional support

Sometimes the customer does not have the time, experience or tools necessary to perform
validation or equipment qualifications once the isolator has been installed. A supplier should
be able to provide or assist with:

Surrogate Testing

Decontamination cycle development

Chemical Indicator Tests

Biological Indicator Tests

IQ/OQ Execution

PQ Execution

Field service and preventative maintenance

Spare parts

In summary, the top 10 considerations for choosing an isolator supplier are:

1. Sales Team knowledge

2. Materials of Construction
3. Controls
4. Location of FAT
5. Operator safety
6. Product safety
7. Quality of Construction
8. Ergonomics (mock ups, 3d models)
9. Documentation
10. Additional support
Visit our website at www.walkerbarrier.com for more information on our products.