The clean team: What's behind this specialised initiative for cleanroom companies?

Professional Partners for Controlled Environment (PP4CE) is a strategic alliance of specialised companies for the cleanroom market. Geerd Jansen, the initiator of the strategic alliance, outlines the thinking behind the initiative and the expertise it has to offer.

^{Globalisation is key}

More and more companies have become more commercially active on an international level. We can see that this has happened in the food, pharmaceutical, semiconductor, and also the medical device sector.

Geerd Jansen says: "More and more we see a global operating production-division. The management of such international groups then formulate objectives such as meeting high, but above all continuous and geographically equivalent quality requirements, continuity of production (preferably 24-7), innovative solutions to problems and of course good value for money. Global partners, for production machinery, raw materials or packaging, are therefore often preferred to local suppliers."

So far nothing new! Let's see what the PP4CE initiative means in this increasingly important globalisation in relation to the objectives pursued by the stakeholders of these international players.

^{A changed world after the latest crisis...}

There are many changes taking place in the global business community. Some of these changes are due to the last economic world crisis. One important change is the implementation of risk management balanced with the increasing use of strict regulations.

"Management has learned from the crisis period, that started about 10 years ago. Among other things, the lesson that risk-management - as a link in identifying, quantifying and limiting or rather completely eliminating risks – clearly deserves more attention. It is not only the financial world that has learned from this. The institute ISO has also implemented risk management in the HLS (High Level Structure) of its management systems,” says Jansen.

Universal standards for the design, production, export and sales of various product segments are increasingly being implemented globally, where many things were previously regulated at a national level. In 2017, the WHO approved a regulation that will introduce new rules for the marketing authorisation of medical devices and in-vitro diagnostics, in the coming years.

Jansen adds: "Because of the new rules, more products are classified in a higher risk class. For manufacturers this may mean a series of changes. Both design, production and distribution processes may need to be adjusted and tested more heavily by Notified Bodies. This also means that the facility, where production and logistics take place, may have to meet higher requirements. GMP regulations, initiated by the FDA, as well as the ISO 13485 - 2016 standards committee, will ultimately anticipate this."

^{10 major risks of global business} 

PP4CE offers turnkey solutions for facilities with controlled environment requirements, on an international level.

^{The ten main concerns of the global business community are:}

^{1. Reputation damage}

^{2. Economic declines or slow economic recovery}

^{3. Increasing competition}

^{4. Changes in legislation and regulations}

^{5. Cyber crime}

^{6. Lack of innovation or inadequate with customer needs}

^{7. Attract and retain inability top talent}

^{8. Interruption of business operations}

^{9. Political risks and uncertainties}

^{10. Legal liability}

^{Source: The world's largest insurance broker and risk advisor AON, conducted its biennial research 'Global Risk Management Survey' in 2017. With international research, for which more than 1.800 CEOs, CFOs and risk managers have been surveyed worldwide, the most important risks for the business community are charted.}

Jansen explains: “In the light of the 10 biggest concerns of the global business community, we see a number of issues that PP4CE regularly faces as an organisation. Examples include customer questions regarding current legislation and regulations, innovative solutions or ideas in the design phase, how to prevent interruptions in business operations and of course the legal liability is always an issue, whether it concerns environmental or safety or product liability! In all cases, reputational damage is the number one risk, especially for markets such as the healthcare or pharmaceuticals.

"Our clients are often companies with large responsibilities, globally active and listed on a stock exchange. Compliance issues therefore always have priority, I know that from my time as a member of the board of directors at BASF Coatings AG.”

More surprising, Jansen says is that the controlled environment facilities in which the production and / or logistics take place, are often designed, delivered and installed by local suppliers.

“I do think the management is taking risks by not using a similar reliable technology, proven to fill in the needs of the organisation and based on uniformity, easier and cheaper in maintenance. Traveling throughout the world visiting factories, I liked to see similar working environment knowing the facilities and procedures where tested and proven concepts!"

"The strategic alliance, PP4CE (Professional Partners for Controlled Environment), offers these conglomerates an international platform for innovative turnkey solutions in controlled environment environments. Not only for the realisation of new construction but also for a responsible maintenance concept that guarantees continuity. If necessary, implemented in an ISO 55001 Asset Management care system. Executed by flexible, professional, reliable and honest companies and their employees!"

^{Professional partners for controlled environment}

PP4CE is a collaboration between experts from different technological areas, including Stulz one of the world's leading companies in energy-efficient temperature and humidity management solutions for mission-critical applications, as well as general HVAC technology; and Brecon International, a Dutch company that represents more than 25 years of experience in designing and building cleanroom technology.

^{Other partners include:}

         ^{• Camfil, air filtration expert;}

         ^{• Assa Abloy, global supplier of entry technology;}

         ^{• Bolidt, expert in the development, production and installation of innovative synthetic bonded floors;}

         ^{• Mennens Cleanroom Cranes, a manufacturer of special CE lifting equipment;}

         ^{• Van Aken Architects, a provider of architectural services in the CE area;}

         ^{• Denios, specialist in laminar and cross-flow booths as well as LAF cabinets.}

Jansen concludes: "With the joint expertise and a global network of all PP4CE partners, PP4CE will be able to create an international platform for the ever-growing controlled environment market segment. The customer has one point of contact, which leads the entire process from design qualification to the implementation of the commissioning and qualification plan.

“The PP4CE approach ensures that no unnecessary loss of time occurs, communication with various parties becomes superfluous. The cooperation with the client is agreed in a clear contract, in which the User Requirements Specifications (URS) as well as the expected qualifications are described, including the agreed time plan for development and realisation. A time plan which in principle is always realised by PP4CE.”