Specifying Pharmaceutical Isolators: What Buyers Should Look For

What Will You Learn From This Blog?

• Understanding the steps to take before specifying pharmaceutical isolators
• Consider how ergonomic design can support your pharmaceutical process
• Explore the questions that help you specify a pharmaceutical isolator manufacturer

Specifying a pharmaceutical isolator is a significant investment that can have a lasting impact on your facility, operators, and manufacturing process. Choosing the right isolator requires careful consideration of how it will perform in your specific pharmaceutical containment environment.

You might believe that the first thing that should be considered when specifying which pharmaceutical isolator suits your process is defining your OEB (Occupational Exposure Band). However, this is not the starting point. Your OEB level doesn’t take into consideration whether an isolator would be able to achieve that level consistently in operation in your lab facility. That’s why specifying a trustworthy pharmaceutical isolator manufacturer is vital.

It’s more important to focus on what the pharmaceutical isolator can continuously deliver, i.e., the protection, longevity, and operational consistency that is needed, rather than whether it meets a band.

According to pharmalliance.ie, “between 2012 and 2023, there were an average of 330 drug recalls annually due to contamination, affecting approximately 400,000 units per incident.” The cost of overlooking operational requirements is high, not only for finances, but for the general public and operator safety.

We have created an easy-to-follow step-by-step outline for specifying the correct pharmaceutical isolator for your operations. This includes the key factors that should be evaluated, such as operator safety, complete containment, made-to-measure ergonomic assessments, process design, and pharmaceutical expertise.

1. Start With Your Process

Firstly, as a buyer, you need to understand the application before selecting an isolator. Fundamental product characteristics, cleaning requirements, and other considerations should be your first considerations, including others such as:

• What product characteristics are needed?
• Can it be integrated into existing workflows?
• Are there cleaning requirements?
• Does your existing facility have any constraints for pharmaceutical isolators?

Once you have understood these main issues, which will highlight your choice in pharmaceutical isolators, you can begin to specify which pharmaceutical isolator would work best for your operations, and which supplier can support you.

For example, after you have aligned the product specifications, cleaning requirements, and overall efficiency that your process needs, you might look to custom containment solutions. It is considered that these made-to-measure specifications deliver better long-term performance than off-the-shelf counterparts, due to operator satisfaction, safety, and workflow efficiency.

But until you have assessed the current containment performance, you should consider all options.

2. Complete Containment: Assess Current Containment Performance

You should consider what your current containment process and performance look like during real operational conditions. Doing so will help you formulate a list of requirements that your next containment equipment should uphold, such as regulatory standards, ergonomically designed equipment, and exposure bands.

OEBs Are Just One Aspect

Understanding the OEB (Occupational Exposure Band) needed for your pharmaceutical isolators is important, but it’s just one aspect of a wider picture.

Before specifying containment equipment, it helps buyers to be confident in understanding what containment technology can do for their operations. Below, we have listed four of the main regulations that should be considered:

• OEB (Occupational Exposure Band): A classification system used to categorise the potency of a compound and the level of containment band required to handle it safely, typically ranging from OEB 1 (low potency) to OEB 7 (highly potent).
• OEL (Operator Exposure Limit): The maximum concentration of a substance an operator can be safely exposed to over a defined period, used to inform containment design, cleaning, and ventilation requirements.
• IQ/OQ/PQ (Installation, Operational, and Performance Qualification): The three-stage validation process is used to confirm that equipment is installed correctly, operates as intended, and performs consistently under real production conditions.
• GMP (Good Manufacturing Practice): The regulatory framework governing the consistent, quality-controlled production of pharmaceutical products, which directly informs containment design and documentation requirements.

Next, it’s important to understand how to protect your operators with made-to-measure containment equipment and ergonomic assessments.

3. Prioritise Your Operators with Made-To-Measure Equipment

Ergonomically designed equipment has a major effect on safety, productivity, and compliance in containment environments, laboratories, and cleanrooms, as it influences how effectively people can perform daily tasks while maintaining containment integrity.

Designs such as glove port positioning and accurate reach distances can prioritise your operators by:

• Promoting operator safety, productivity, and compliance
• Reducing operator fatigue, repetitive strain injuries, and human error

A fully bespoke, operator-led containment solution, built around a formal ergonomic assessment, becomes important where you’re working with higher OEB band materials, where your facility has specific spatial or layout constraints, where operator teams vary significantly in size or physical range, or where the process involves complex multi-step handling that a standard design wasn’t built to accommodate.

Typically, ergonomic assessments can be carried out on-site, at the equipment supplier’s HQ, or both.

Interested in an ergonomic assessment? Learn more.

Now that your operators are prioritised by ergonomic design, you should consider that your equipment and supplier can ensure regulations are upheld.

4. Ensure Regulations Are Upheld

Effective pharmaceutical containment design must meet stringent regulatory expectations while ensuring safe, reliable operation throughout the facility lifecycle.

Plus, designing for cleanability and contamination control means eliminating areas where product residue can accumulate, supporting efficient decontamination, and reducing the risk of cross-contamination.

Ensuring that you have made careful considerations of containment performance, material selection, and hygienic design principles will help maintain product integrity while protecting operators and the manufacturing environment.

The right pharmaceutical containment supplier should be able to provide you with:

• Robust documentation
• Validation
• Qualification support

Plus, they should be able to provide the evidence required for regulatory compliance and streamlining IQ, OQ, and PQ activities. By designing flexible, future-ready containment solutions that can adapt to evolving GMP requirements and changing manufacturing processes, organisations can protect their investment while maintaining compliance and operational efficiency for years to come.

In turn, this further provides you with the information on your chosen supplier’s engineering expertise.

5. Built For Longevity: Consider Lifetime Support

Once you have decided on the pharmaceutical isolator, it’s time to consider what the supplier can provide after initial installation. Here are some considerations:

• Installation: Ensure the supplier has the expertise to install the isolator correctly, integrating it with your facility while minimising disruption to operations.
• Commissioning and training: Confirm that the supplier offers comprehensive commissioning services to verify performance, along with operator and maintenance training to ensure safe, efficient, and compliant use of the equipment.
• Preventive maintenance and servicing: Regular preventive maintenance helps maintain containment performance, reduce unplanned downtime, and extend the lifespan of the isolator. Look for suppliers that offer planned service agreements tailored to your operational needs.
• Spare parts availability: Ready access to genuine spare parts is essential for minimising downtime and ensuring repairs can be completed quickly when required.
• Technical support and long-term partnership: Choose a supplier that provides responsive technical support, troubleshooting, upgrades, and ongoing guidance throughout the life of the isolator. A long-term partnership can help ensure your containment solution continues to meet evolving operational and regulatory requirements.

Once you’re sure, it’s time to get ready to question your pharmaceutical isolator suppliers.

6. Question Suppliers Before Specifying a Pharmaceutical Isolator

To identify the ideal supplier, ensure you have a comprehensive list of questions for potential suppliers to address. We have created concise examples that you can ask about below:

• Are controls tailored to the process, operator roles, and skill level?
• Is the equipment specifically designed for operating in pharmaceutical environments?
• Are industry certifications, such as ISO standards and GMP regulations, current and clearly evidenced?

You can find our entire list of questions in our buyer’s checklist. This checklist helps you assess containment suppliers, including your current one. Any unchecked box or unanswered question represents a potential risk worth further investigating.

Download Your Buyer’s Checklist Today

Hosokawa Micron Ltd.’s pharmaceutical containment expertise helps you specify isolators that suit your containment facility.

Discover what’s possible for your containment practices. Download our buyer’s checklist, which contains all the latest insights into our pharmaceutical expertise, and a simple checklist supporting you in choosing the right supplier.

Download Now

If you have any other questions, you can get in contact with our expert team.