Product and personnel protection through cleanroom technology: particle-free work in the GMP environment with optimized HygienicSafe devices

If manufacturers rely on suppliers or external materials for the production of pharmaceuticals and implants, the use of a so-called Restricted Access Barrier System (RABS) is possible. These ensure a highly pure working environment, in which interventions are only possible through permanently installed gloves. All materials are introduced into the work area via an airlock system, guaranteeing an undisturbed manufacturing process. (Source: bc-technology GmbH)

HygienicSafe is optimally adapted for a wide range of applications in the GMP environment, enabling flawless and efficient work in accordance with legal regulations and binding standards. (Source: bc-technology GmbH)

HygienicSafe is optimally adapted for a variety of applications in the GMP environment, thereby enabling flawless and efficient work in accordance with legal regulations and binding standards. (Source: bc-technology GmbH)

HygienicSafe is optimally adapted for a variety of applications in the GMP environment, enabling flawless and efficient work in accordance with legal regulations and binding standards. (Source: bc-technology GmbH)

The operation of HygienicSafe devices can be conveniently carried out via a clear touch panel. (Source: bc-technology GmbH)

Dr.-Ing. (FH) Carsten Gäßner founded bc-technology GmbH in 2005 and has been responsible for the management since then. As head of the Device Technology Department, he is also responsible for the research and development of the company's cleanroom equipment. (Source: bc-technology GmbH)

Numerous steps in pharmacy, medical technology, biotechnology, food, and cosmetics industries require excellent quality in cleanroom technology and documentation to ensure product safety and minimize rejection rates. To guarantee safe working conditions, Good Manufacturing Practice (GMP) creates the framework for the production of highly sensitive products. This ensures a pure manufacturing and production environment through version-controlled documentation according to a predefined lifecycle, qualification, equipment validation, and risk management. Due to these strict regulations, it is a particular challenge to comply with the mandatory standards for cleanroom technology in production.

"To meet these high requirements in the GMP environment, our cleanroom equipment of the HygienicSafe line has been optimized," reports Carsten Gaßner, Managing Director of bc-technology GmbH. "They are characterized by numerous options and implementation possibilities. Over several years of development, a total of 6 device types with more than 60 defined standard devices have been created, which can be further expanded with a total of 39 options. This makes them tailored to the needs of the GMP environment and ergonomically and sound-optimized. All devices comply with the cleanliness class A according to the EG-GMP guideline, Annex 1, as well as cleanliness class 5 according to DIN EN ISO 14644-1." Through the optimal adaptation of HygienicSafe to the application areas in the GMP environment, flawless and efficient work is enabled in accordance with legal regulations and binding standards.

Adaptable Construction

With HygienicSafe, bc-technology combines cleanroom devices that are designed as workstations, machine attachments, cleanroom cabins, or as special weighing and sample transfer cabins. "We differentiate solutions for pure product protection and variants for additional personnel protection," explains Gaßner. The clear structuring of all HygienicSafe devices aims to help users quickly and safely find the appropriate device type. In pharmacy, much of medical technology, as well as the food and cosmetics industries, a surface resistant to disinfectants must be guaranteed. For this reason, HygienicSafe is standardly made from V2A stainless steel 1.4301. In special cases, V4A stainless steel 1.4404 can also be used.

"Thanks to a wide range of options, the devices can be ideally adapted to any work area," Gaßner continues. "For example, in some devices, the exhaust air can be connected to the building's ventilation system. Another option is upgrading with molecular filters to clean the air from gases and chemicals. The possibilities are diverse." For instance, manufacturers involved in sterile filling of pharmaceuticals can use a so-called Restricted Access Barrier System (RABS). These ensure a highly pure working environment where interventions are only possible through fixed manipulators or gloves. All materials are introduced into the work area via a pass-through system, ensuring an undisturbed manufacturing process.

Horizontal and Vertical Airflow

"Additionally, we offer solutions with horizontal and vertical airflow," reports Gaßner. "Each of these variants is suitable for different applications. In horizontal airflow, all airborne particles are flushed from the front side of the work area, while in vertical airflow, particles are extracted through the work surface." Both airflow types thus ensure product protection. If a device also needs to provide comprehensive personnel protection, a recirculation principle is used, where exhaust air is cleaned with special filters. This prevents contaminated air from escaping into the room. In areas of personnel and environmental protection, specific custom solutions are the norm.

Pre-Sale Service Enables Process-Related Solutions

"HygienicSafe devices for personnel and environmental protection, such as weighing cabins, are frequently used in highly sensitive or hazardous processes," explains Gaßner. "Especially with these devices, there is often a move away from standard products towards customer-specific custom solutions. Therefore, consulting on the implementation of cleanroom technology is always recommended beforehand. Particularly, discussions about system requirements are crucial to develop suitable solutions for specific work environments." For example, the HygienicSafe weighing cabin is suitable for manual filling processes of powder-form substances in a microbiologically controlled production environment. Its triple recirculation filter system and downward-directed clean air flow ensure reliable product and personnel protection even in case of failure. A built-in air cooler maintains a consistent working temperature, and modern touch panels allow programming of measurement, control, and regulation technology.

"Since a weighing cabin is often used for working with hazardous active and auxiliary substances in the pharmaceutical industry, we examine each process individually, searching for critical parameters, sources of interference, and interface issues," concludes Gaßner. Whether for standard products or custom-designed cleanroom technology, the company guarantees safety for the customer through GMP-compliant documentation and provides proof that the devices meet the required cleanliness class and limit values.