Whitepapers

“A shutdown in a production facility is an event where an entire process plant or unit has to be put out of operation in order to carry out specific maintenance tasks and/or other work”. A plain and, at first sight, simple description of a necessary evil. But also a situation which, when announced, is often the start of an tense period of time. Usually the shutdown is an event that can keep a senior management awake. All in all, shutting down production often causes problems: no output, high costs for carrying out extra (indirect) work and overall often leading to a logistical problem. In other words: a shutdown often has a negative economic impact on the company! How can we increase the efficiency of a shutdown and avoid unnecessary waste of time? What are the pitfalls and what do we need to think about in the case of a planned shutdown? This is an interesting issue that we want to highlight in this white paper.

Safe and efficient hoisting and lifting is essential in controlled environments. There is a lot to consider. From choosing the right materials and cable trays to having dedicated software developed, no two controlled work environments are the same. Companies themselves set very diverse requirements, and regulations differ for each sector and country. Discovering success factors in three areas of focus can help filter the best options. And ultimately make choosing the best cleanroom crane for your company or industry much easier.

Working in a room in which the climate conditions are controlled and the contamination of the air (pollution by dust particles, chemical or micro-biological pollution) is constantly kept at a certain desired level has enormously increased over the past decades. Such Controlled Environment (CE) facilities are often referred to as Cleanrooms in the semiconductor and pharmaceutical sectors. Other sectors also use more specific terms, such as OR (Operating Room) in health care or a Medium/High Care room in the food industry.

Many market segments require investments in a controlled environment. A controlled environment area can mean a clean room, a laboratory in general, a medium or high-care room in the food sector, but also a surgery room in the health care sector or a Bio Safety Lab (BSL). In specific production technology sectors, investing in a clean room is compulsory, e.g. pharmaceutics, cosmetics or medical devices.In this white paper, we will talk about a pharmaceutics clean room as an example. Nevertheless, the content of this white paper is similar for all other controlled environment areas mentioned above.

Closing a room is one thing, closing a room where products are disinfected with hydrogen peroxide in the form of a gas (VHP) is a completely different story. If that gas escapes, serious accidents can happen! In a Controlled Environment facility you will often find different doors, such as single or double revolving doors, sliding doors, roller doors or gas-tight doors, as well as other variants. In this white paper you will be introduced to the variation of (cleanroom) doors and their specific properties.

When Brecon decided at the start of 2016 to develop a new wall and ceiling system for the international GMP-related market segments, it was clear that we had begun a challenging and innovative process that would be coupled with some sizable investments in energy, time and capital. A long road that also involved researching materials, developing the right profiles and a constructive composition of the building system, evaluating the right parts for the windows and doors, searching for innovative solutions for air transport and a list of hundreds of activities ultimately led to the current BCPS (Brecon Cassette Panel System). But how were we ultimately going to convince the international market that our system was actually certified for ISO 14644, GMP and EHEDG classified facilities?

Food safety is becoming an increasingly important topic on the international market. In order to guarantee the safety and quality of our food supply, statutory food safety regulations are applied on various continents and guidelines and regulations are in force for the various disciplines in this important sector (such as e.g. production, storage and transport). Is there a common denominator in that web of regulation? There is indeed one topic that takes a central role around the world and is addressed by all the relevant legislation and guidance: the obligation as a producer to make a risk analysis and accordingly equip the facility in such a way that quality and food safety is guaranteed. The GMP rules in the US have been modified to take account of this and a new chapter has been introduced in the Code of Federal Regulations (CFR Title 21 part 117), which is becoming increasingly important a year and a half after its introduction.

The WHO considers the global lack of food safety to be one of the greatest threats to global health. Market research has led Professional Partners for Controlled Environments (PP4CE) to conclude that a large proportion of Dutch and Belgian companies in the food industry have insufficient knowledge of risk-reducing measures by zoning within their production area. Introducing contamination control measures can be a first step towards gaining a better insight into this risk.

Of course, food safety has been an extremely important topic in the food industry for many decades already. In principle, the food business operator itself bears full responsibility for safe and hygienic process control. If the Netherlands Food and Consumer Product Safety Authority(NVWA), in its capacity as the monitoring and enforcement authority in the Netherlands, identifies problems in your production process as a result of an interim inspection or a problem identified by third parties, you will be held accountable. Each country has its own authority taking care of food safety issues. So in this White Paper we are using the marketing report, based on research in Holland and Flanders. Be aware that not only in Holland, but in any other country penalties for incorrect handling, or product recalls, create major economic consequences.

GMP classified cleanrooms, for example in the biomedical or pharmaceutical industry, should have a controlled level of microbiological contamination. The standard for microbiological contamination in the air or on horizontal surfaces is of great importance and is closely monitored. This article gives an idea of how a good cleaning regime can make a successful contribution to achieving these important objectives.