Choose Pharma 4.0 in Your Pharmaceutical Clean Room

How long was your pharma manufacturing line shut down following the last microbiological contamination event? How long until you even knew what the contamination was so you could apply the appropriate response? What was the cost? Let's talk about getting your response time down to less than 2 minutes.

Book a chat to talk about real-time viable particle counters for pharma today

You’re subject to strict regulations, and your cleanroom needs to meet rigorous standards.

We’ve consulted on hundreds of Grade A and B manufacturing suites with Grade C and D supporting areas, where viable and nonviable particle counts are under heavy scrutiny. Manage or meet a high level of patient safety through product manufacturing excellence, while meeting FDA or EU GMP regulations.

Are you a compounding pharmacy? We understand the challenges of your work under USP 503A and B, or USP 797/800, and help you work confidently with all the nuances you balance daily.

Here, you find the right selection of instruments for pharmaceutical or compounding cleanrooms so you don’t have to spend days doing your own exhaustive research.

Most pharmaceutical companies work with us for:

TSI Real-Time Monitoring Systems

Process Equipment Qualification and Validation

Viable Impactors

Isolators or containment

Wheel and Foot Borne Contamination Control

Special pricing is available for your organization

Pharmaceutical clean room builds and retrofits often call for a large volume of purchases. When your order includes multiple units and multiple instruments, we can offer better pricing. As the size of your order grows, the discount grows.

Contact us to set up preferred pricing for your organization, so you know you’re getting the best value every time you work with us.

Stop contamination at the source
Contamination enters your pharma process from three sources:

Technicians

Air

Water

The people doing the job are essential. They can’t be taken out of the equation.
So their impact has to be controlled.

Human contamination comes from their skin - shedding skin and the microorganisms that live there. It comes from inside the body - bacteria or viruses they might not even know are there. It comes from sources like mascara or eyeshadow or other cosmetics that seem innocuous.

Air contamination is everywhere outside your cleanroom, fighting to get in. It’s dust, and the spores and bacteria riding on the dust motes. More times than not, the bacteria hitching a ride into your cleanroom on a tiny speck of dust is viable and capable of spoiling a lot of product.

Water contamination comes from two sources - the liquids used to decontaminate spaces and the water that goes into pharmaceutical products.

So, to reduce the human as transporter:

Proper gowning and aseptic techniques are the keys, and the use of unidirectional airflow wherever possible in your workflow.

For that, we recommend a cleanroom. Which cleanroom is right for you? We'll walk you through the process so you can confidently choose the correct hardwall, softwall, modular, or booth cleanroom for your application.

Leading pharma companies also prefer particle counters and real-time monitoring systems from TSI, so contamination events can be identified and controlled rapidly.

To reduce air as transporter:

Control airflow through air handling units.
Work unidirectionally whenever possible.
Install airlocks at appropriate locations.
Install HEPA filters or Ultra-Low Particulate Air Filters where even greater certainty is needed

And to reduce water as transporter:

Water is one of the most common ingredients in pharmaceutical products, and also a huge source of contamination. Pathogens and bacteria can contaminate production cycles, but so can minerals commonly found in most water sources.

Water filtration is your best tool, and that could be reverse osmosis, ultrafiltration, distillation, or even UV treatment of all inbound water.

Get help with best practices for your pharma cleanroom

You already know most of the best practices to control contamination in your pharmaceutical cleanroom. Maybe you’re an expert and you know it all.

But don't you want to be sure?

Maybe your legacy environmental monitoring SOP hasn't been updated since the regulating bodies changed the standards a few years ago.

Maybe you're actually in danger of getting dinged by an auditor and you don't even know it.

Maybe a process in your workflow is inadvertently introducing risk into the cleanroom.

Maybe parts of your contamination control system are creating hazards for operators.

Maybe you're overdoing it or underdoing it or doing everything exactly right.

Effectively protect your production space from physical, chemical, or biological contamination

Physical contamination might come from a small break in the oil seal of the reactor. Exposing the product inside the reactor to the environment.

Chemical contamination could come from solvent cross-contamination, where recovered solvent is stored in a drum that was already used, but not properly cleaned.

Biological contamination often comes from powder processing equipment being left damp after cleaning with water. Microbes proliferate in the equipment and contaminate the next batch of powder in the equipment.

That’s a lot to think about. We help you do it by working closely to identify the best products and instruments (and processes, if you want) to cover the entire prevention lifecycle

Prevention means to:

Identify the
contaminant

Anticipate the contaminant

Prevent ingress

Facilitate egress

Minimize internal generation

Control residual contamination

But what are you missing?

Contact us today to validate your processes, qualify and source your equipment, and connect with the best and most responsive technical support you’ll find from any manufacturer’s rep (and manufacturer too) in the country.