Whitepapers
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 | Investing in a controlled environmentMany 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. |
Investing in a controlled environment
| Door Technology in Controlled EnvironmentClosing 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. |
Door Technology in Controlled Environment
| Fraunhofer Certification of the Modular BCPS Cleanroom SystemWhen 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? |
Fraunhofer Certification of the Modular BCPS Cleanroom System
| cGMP IN THE FOOD INDUSTRYFood 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. |
cGMP IN THE FOOD INDUSTRY
| Contamination Control within the food industry.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. |
Contamination Control within the food industry.
| PP4C has market research carried out in Holland and Flanders within the food industry.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. |
PP4C has market research carried out in Holland and Flanders within the food industry.
| White Paper - Cleaning and disinfection in the GMP cleanroomGMP 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. |
White Paper - Cleaning and disinfection in the GMP cleanroom
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