A note about IVF cleanroom integrity.

IVF image

Thanks to Validair, IVF clinics can now ensure absolute integrity of the highest value product in assisted conception. Commercial Director Deborah Haisman explains.

The cleanliness of the environment is imperative in the IVF sector to protect against contamination. But how can people who work in that sector be certain that contamination is under control? One effective way is to deploy Airborne Particle Counters (APCs) to monitor the environment. We know this because our particle monitoring solutions contribute fundamentally to countless successes in the assisted conception sector.

Just like GMP pharmaceutical facilities, the high value ‘product’ must be protected from contamination at every step of the production journey. But curiously, unlike pharmaceutical production regulations and licencing, continuous particle monitoring is not mandated in the HFEA sector. We think that’s rather odd. Sure, in the past, cleanliness control was viewed as a ‘nice to have’ alongside more critical issues around micro, VOCs and temperature control.

But the industry has upped its game in recent years – and EU directives now mean that particle control is required. Without a method or mechanism to measure that, how can that control be proved? Or documented to provide assurance?

Surely, you’d want to do everything possible to ensure the right outcome. It’s easy for a facility to become ‘dirty’ through contamination. Small particles can cause big problems and those without solutions like an APC won’t know.

High stakes

In pharmaceutical production, a failure results in the loss of a high-value batch of product. But continuous particle monitoring will raise the alarm and prevent further batch contamination. For assisted conception, unseen and unknown particle contamination can result in failed cycles time and again, with no way of knowing why cycles fail; or even if a particle contamination problem exists.

Assisted conception is a very dynamic process. Unlike pharma manufacturing, it’s not a mechanical production process so it doesn’t lend itself to continuous particle monitoring in fixed locations that are typically identified by expert assessments of likely contamination risk points. Instead, for this type of application, periodic monitoring and ‘in process’ monitoring are the most valuable tools to help ensure the cleanliness of the environment.

The advanced measurement solutions we offer at Validair, manufactured by world leader TSI Inc., deliver the confidence needed to certify a cleanroom, monitor a process or track down a root cause using real-time particle monitoring information. It lets you make immediate changes to processes and procedures.

These solutions are the best for many reasons. Our range of AeroTrak™ particle monitoring instruments deploy the very same technology as the TSI Global Gold Standard Reference Instruments. They are trusted by Standards Institutes and National Laboratories worldwide, including these fine organisations:

  • National Institute of Standards and Technology (NIST)
  • Japan Advanced Institute of Science and Technology (JAIST)
  • US Department of Defence
  • US Centre for Disease Control
  • PMS / MetOne / LWS

It’s notable that those last three organisations are our competitors; they use TSI Reference Instruments to calibrate their own products. In fact, why would anyone not use the same highly accurate particle monitoring instrument technology that sets the standard for all other particle monitoring instruments? That’s why we offer a suite of reliable TSI AeroTrak instruments to ensure the perfect measurement every time.

Using AeroTrak particle measuring instruments in conjunction with the TSI TrakPro™ Lite and FMS 5.0 software assures data integrity. It means users can conduct monitoring at any time during their process and link that information to patient records. And ultimately refer that data to their cycle success rates without compromising data integrity. It can even form part of a GDPR policy.

Here’s how we help.

It’s simple. We are experts in the supply and installation of bespoke continuous environment monitoring and critical alarm systems. Our applications include pharmaceutical production facilities, life science cleanrooms, healthcare facilities, laboratories, storage and distribution centres, and many other critical controlled areas and equipment. Validair Monitoring Solutions Ltd is accredited by UKAS to ISO17025 (Laboratory Number 9791) for temperature.

We are uniquely placed to provide state-of-the-art integrated environmental monitoring systems and high-quality particle monitoring instruments. We also understand the need for regulatory compliance and have the experience to help ensure our customers remain compliant with regulatory auditors. Combined with our on-site service and calibration support for our instruments, it sets us apart from our competitors and product distributors.

The AeroTrak 9306 Handheld and 9510 Portable particle monitoring instruments are ideally optimised for the assisted conception market. We’re keen to talk to people in the HFEA sector about how they can be used as highly effective survey tools to rapidly track down particle contamination sources and classify clean areas to ensure integrity and save money. We’ll tell you about ease of use too, including why professional certifiers prefer the icon-driven functionality. Or how long sample tubing lets you perform tests at multiple locations.

Get in touch with us if you’d like to know more or would like a demonstration. You are welcome to email me directly.

Deborah Haisman

Commercial Director

Debs Haisman