Unmatched Flexibility in Batch Production: The Balancing Act of Grams and Kilograms

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R-Pharm Germany GmbH

How Containment Ensures Flexibility at its Best

For example, it became clear very quickly that a classic isolator concept would restrict the flexibility we needed. Development and small-batch production take a lot of manual labor: Equipment can change frequently, devices need to be cleaned often, samples are taken, etc., which is why R-Pharm used a room containment concept. Specifically, this means that processing is completed in a climate-controlled room at negative pressure that is hermetically regulated via a sealing system to ensure outside areas are not contaminated.

Success Factor Containment

Safe Contract Manufacturing With Zero Contamination

Pharmaceutical technicians work in ventilated protective coveralls when handling OEB 4/5 drugs. All of the equipment is mobile and equipped with castors that allow it to be moved as needed. This lets employees combine equipment for each specific task, then decontaminate it after it's used in the cleaning room. That means qualifications, maintenance, and cleaning of unused machines can be completed at the same time as ongoing processes.

“This gives us the mobility we simply need for development,” Hänel explains. Although this sounds relatively simple, in reality it was a major challenge for equipment manufacturers, as the equipment needed to be exposed to excess pressure and sealed to ensure no dust would penetrate it. “We simply couldn’t use off-the-shelf systems,” Hänel emphasizes.

Pharma, Packaging and Storage Solutions at Achema 2015

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Flexible Batch Production and the Heat Issue

The biggest problem is heat development, since stand-alone devices all have switch cabinets with ventilation slots — a major problem when it comes to dust. If you need to seal off those slots, where does all the heat go? Especially for fluidized bed systems, Glatt technicians needed to play the trickster to get equipment ready for containment.

“An ingenious ventilation system was used to vent heat from the machines out of the technology area, while at the same time preventing dust penetration — a highly effective solution for both problems in ‘one fell swoop,’” explains Michael Maintok, containment expert at Glatt. Glatt provided seven small batch coaters and granulators with appropriate technical adaptations to the PPDC for granulating and coating.

High Containment

High Containment Processes in the Solid Drugs Production

How a Smart Room Concept Prevents Cross-Contamination

The entire production area consists of three rooms: two production rooms and a cleaning room between them. That means the “hot zones” for core processes are spatially separated and have different climate control systems, while other areas can be used together. After a campaign, the employees can push used equipment through the lock and into the adjacent cleaning room, then from there into the neighboring production room, where it waits clean and ready for its next use. The safety laboratory used to analyze highly active substances is also new.

The PPDC is connected to the “high potent lab” via alpha/beta ports. Isolators, safety work benches, and flues ensure safe working conditions without additional protective equipment. This equipment will also be useful in the future, if even more potent materials are used for development.

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