Fette Compacting
Tags: WiP + ContainmentHPAPIFE55FE75  

EFFICIENT IN CONTAINMENT

Tablet presses for processing toxic substances

The trend towards high-potency APIs in drug manufacturing is having a knock-on effect on the tableting process. There is growing demand for containment systems to guarantee high safety standards for operators and products alike. So what are the associated requirements and which system is best suited to what type of production?

More and more tablets contain highly potent APIs. Modern processes such as hot-melt extrusion can be used to bind the substances to form powders or granulates and press them into tablets. Following administration, the formulations release a precise dose of active ingredients in the body. Two trends are emerging: one towards orodispersible tablets, which dissolve in the mouth, and the other towards delayed-release preparations that deliver active ingredients into the gastrointestinal tract.

“High-potency drugs make the greatest demands on the tableting process,” explains Jörg Gierds, Head of Product Management at Fette Compacting. “A tablet press has to compress powders and granulates safely and efficiently. We have therefore defined the following objectives for the associated containment components: no release of dust during production or preparations for cleaning, no contact with toxic products, a waterproof and dust-tight compression chamber, and maximum operator safety throughout the entire production process.”

Integrated containment from filling to washing

To achieve these objectives, containment solutions need to be integrated into the process and not concentrated on individual machines. Every technical interface needs to be designed to ensure that all the connections from end to end are sealed. For example, the docking system used for powder or granulate filling should be fitted with double-flap valves so that no dust can escape. The compression chamber itself must also be completely sealed. Fette Compacting has developed an enclosed compression chamber with inflatable seals for this purpose, which prevents even the tiniest dust particles from being released.

The tableting process should be as fully automated as possible. Ideally, there should be no intermediate manual steps – and therefore no break in the containment – between the filling of the machine and the removal of the tablets. However, in the case of machine stoppage, operators must have manual access from every side of the tablet press without breaking the containment. Glove ports in the window flaps are the most important means of ensuring this.

Even after production, containment tablet presses pose special challenges for both operators and technology. In the case of enclosed facilities, all of the components must be individually logged and washed using a program. With WiP and containment tablet presses from Fette Compacting, washing programs can be configured and saved for specific products. An automated washing process and easy handling of the machine components can save tablet manufacturers a lot of time.

Operator protection from conventional tablet presses to high-containment units

The class of containment tablet presses caters for three levels of toxicity. Single rotary tablet presses can be used to safely compress substances with a low level of toxicity up to OEB Level 3. WiP/containment tablet presses with standard process equipment are needed for toxins up to OEB Level 4. Highly toxic substances up to OEB Level 5 have to be processed using a WiP/containment tablet press with complete containment and integrated process equipment. You can find information about the different machine specifications on the opposite page.

OEB Level 3OEB Level 4OEB Level 5
Toxicity levelSlightly poisonousPoisonousHighly poisonous
maximum dust contamination (OEL)10-100 μg/m³1-10 μg/m³< 1 μg/m³
maximum active material level (AML)1-10 mg/day0,1-1 mg/day< 1 mg/day
Examples of active materialsPainkillers, hormonesPainkillers, hormonesCytostatic agents, hormones
Machine typeWiP tablet press, washable, and FE55 with containment package for conventional cleaningWiP/containment tablet press and standard process equipmentWiP/containment tablet press with complete containment and integrated process equipment
Machine equipmentFor WiP presses:
– washable tablet press
– changeover of the die table package
– automatic emptying of the filling equipment
– no internal coverings
– encapsulated system

For FE55 with containment package:
– butterfly valve for secure product feeding
– hermetically sealed and lockable window flaps
– RTP accesses for removal of components or tablet samples
– dust-tight tablet outlet
– H13 HEPA filter
– vacuum wand for preliminary cleaning
– interface for OEB3 deduster and IPC unit
– washable tablet press
– changeover of the die table package
– automatic emptying of the filling equipment
– no internal coverings
– encapsulated system with gloveports for operations on the tablet press
– no contamination with toxic products
– high safety during cleaning
– access to the compression compartment via a rapid transfer port system (RTP)
– washable tablet press
– changeover of the die table package
– automatic emptying of the filling equipment
– no internal coverings
– encapsulated system with gloveports for operations on the tablet press
– no contamination with toxic products
– high safety during cleaning
– access to the compression compartment via a rapid transfer port system (RTP)
– patented air management system
Available tablet presses

1090i WiP
2090i WiP
3090i WiP
FE55 and FE75 with containment-package

1090i WiP
2090i WiP
3090i WiP
1090i WiP
2090i WiP
3090i WiP

Fette Compacting tablet presses for OEB Level 3, 4 and 5

FE55 and FE75 now available with optional containment package

Users can mass-produce more than 90 percent of all products with the FE55 high-performance rotary tablet press and the double-sided rotary press FE75. From now on, that also includes all toxic APIs with particulate contamination levels of 10 to 100 μg/m3 because Fette Compacting is offering the FE55 and the FE75 with optional containment components such as RTP access, glove ports, and simple parameter control via the machine terminal.

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