In the run-up to Cleanroom Technology Conference 2019, the event is already showing strong delegate registrations, up 63% compared to this period for last year's event. If numbers are anything to go by, the two-day showcase for all things controlled environments and cleanrooms will be another hit in Birmingham.
In its third year running, our conference has become a staple in the events calendar. Scheduled to open on 21 May at the National Conference Centre (NCC), Cleanroom Technology Conference 2019 returns with a showcase of products and services from 78 exhibiting companies: laboratories, equipment manufacturers, consulting services, and others. All manner of which will be present on the show floor in excess. With a sold-out exhibition floor, there is something for everyone!
The feedback we have received about the event is positive and every input has been taken in consideration in planning this year’s outing. We know that delegates and exhibitors appreciate the network opportunity and our team is working on the finishing touches to deliver a bigger and better experience. A closer look at what's in store reveals the result of this effort.
Attending the conference is a high-calibre speaker line-up and the agenda has been curated to present hot topics in the market of pharmaceuticals, food, and hi-tech industries.
With such a broad spectrum of issues to cover, the conference will debut a new format this year. In a move to ensure delegates get the most of the programme, sessions will be on different streams with a dedicated focus theme: Compliance and regulation; Design and Operation; Cleaning and Disinfection; Hi-tech Manufacturing; and Food Processing.
Attending the conference is a high-calibre speaker line up and the agenda has been curated to present hot topics in the market of pharmaceuticals, food, and hi-tech industries.
Industry standards
Updates to various parts of ISO 14644 are an example of today's sweeping regulatory changes that will be dissected by the conference speakers.
Chairing day one, Gordon Farquharson, Director and Principal Consultant of Critical Systems, will set the scene with a presentation entitled “There’s more to GMP than waiting for Annex 1”. The talk, he says will provide a better understanding of the path from ISO to good manufacturing practice. A GMP expert, Farquharson's advice will focus on the decisions to make now for facility upgrades and line-extensions.
Several questions remain today around the UK and the post-Brexit effect in businesses. The potential impact on regulations and the supply chain are issues that Lynne Byers, Executive Director, NSF Pharma Biotech, will clarify at the conference. “[Brexit] is immensely topical at the moment. While the date of the UK leaving the EU is not certain there is some certainty about how medicinal products will be managed,” she tells me. Byers emphasises that her presentation will cover precisely that area, including how the EU will treat products manufactured in the UK and exported into the EU and how products made in the EU and then exported into the UK will be treated.
“The requirements are different, so come to the presentation to learn about the distinctions,” she enthuses. Both Farquharson's and Byers’ sessions are on the Compliance and Regulation stream.
There is more on the regulatory front that would impact cleanroom construction. The forthcoming ISO 14644-16, the new chapter with guidance for users to minimise energy consumption and cost of their cleanrooms, is out for comment at the various international industry bodies and it is expected the document will be released later in the year. Keith Beattie, Life Science Lead at EECO2, was in the team of experts who drafted the standard, and he will reveal details of the document at the conference.
“There are new technology approaches that will radically change the way that cleanrooms operate,” he tells me, remarking that the new standard considers energy efficiency in a broader sense. For Beattie, environmental sustainability is a concept that should be taken very seriously, in the context of both cost-effective operations and minimising impact of climate change. “If you want to learn about the key aspects to consider, how to go about improving your cleanroom energy performance and some new technology approaches, then please join me for this session,” he says. Beattie's presentation is booked on the Hi-Tech stream.
GMP and contamination control for the food industry is the topic of choice by Geerd Jansen, General Manager of cleanroom builder Brecon International. Jansen will reveal the findings of research carried out in the Netherlands and Belgium regarding food safety. “We were surprised by the lack of knowledge regarding the hygienic concept in food safety,” he tells me, noting that 50% of the surveyed professionals didn't know what a high-risk or medium-risk is. “This is worrying," he says, “because these concepts are on par with GMP grade A, B, C, and D in the pharma industry. Imagine what would happen if half of the pharma industry didn't know this!” he remarks.
Jansen, who also spearheads the Dutch network of cleanroom technology specialist, PP4CE, thinks the controlled environments industry should focus on the food market and tap into a range of business opportunities that emerge from the study.
He explains: “Developments and regulations, particularly in the US with the FDA, are more and more emphasising food safety, GMP manufacturing and certification. These changes imply several challenges for the manufacturer, and I see companies are only starting to realise that building materials and the technology chosen for their food processing environments play a vital role in defining the high- and medium-risk areas.”
Cleaning and Disinfection
Familiar faces return to the conference with topics that will spark audience participation and debate.
Ecolab’s James Tucker will walk us through a practical approach to measuring cleanroom residues from manual disinfectants, and technical expert Walid El Azab of Steris, will talk about the recurring microbial contamination in grade A (ISO Class 5) filling restricted access barrier system (RABS).
“The presentation is based on a case study,” El Azab tells me. “The takeaway message is the lesson learned from how inappropriate, or inefficient cleaning and disinfection practices, may have a huge impact not only on the environment but also on the product,” he explains.
In his presentation, El Azab will also comment on latest FDA warning letters to pharma companies where environmental monitoring (EM) data has not been adequately reported. “This is a recurrent issue described in several Form 483 that has been issued to companies recently. This not only affects the sterility assurance of the product being released but also its quality,” he notes.
EM is at the heart of every cleanroom and John McKenzie, CEO of Wickham Laboratories, will take to the stage to shed light on the testing requirements and practice of providing pure water and the testing of pure water in contract labs. Also on this stream are planned presentations covering aseptic manufacturing and the human factor. Pharmig’s David Keen will share tips and tricks on how to nudge people out of error.
When it comes to monitoring technology, particle counters come to mind. Andy Worsick, Applications Manager, EMEA at Air Techniques International, is presenting a comparison of the different techniques under ISO 14644-3. “The session will look at understanding when the photometry method is best and when the particle counter is better. There is a time and a place for both methods and it all depends on the application,” he explains.
There is so much more on the agenda; I trust this preview is something to whet your appetite.. Visit the conference website for more details and book your ticket.
Cleanroom Technology Awards 2019
Building on the success of the inaugural 2018 edition, the Cleanroom Technology Awards is back! Four categories are in competition and the deadline for entries is 18 April. Here is what you need to know to have your brand in the spotlight.
Best Cleanroom Facility: This category is open for design and build companies as well as facility operators. Entrants will be judged on detail and visual information, use of innovative technology, energy efficiency, sustainability and project scope. Entries must have been completed within the last 24 months and should be operational.
Best Cleanroom Innovation: This category is open for designers and manufacturers of cleanroom products or solutions. Entrants will be judged on product innovation, likely impact on the cleanroom sector and clarity, detail and visual completeness.
All exhibitors are also invited to nominate one of the products on display at the conference for one of two categories:
Best Exhibitor Product - Consumables
Best Exhibitor Product - Technology
