POWTECH exhibitors present the latest solutions
The new GMP Annex 1 regulations have further strengthened the trend towards the use of containment solutions in the pharmaceutical and chemical industries. The need to safely handle highly active substances and protect them from contamination has increased the demand for containment systems. These systems enable the sampling, dosing and processing of hazardous substances under strict safety conditions.
An important aspect in the selection of containment solutions is the distinction between rigid and flexible containment. Each of these solutions has its own advantages and disadvantages.
An often underestimated activity in the production of active pharmaceutical ingredients or toxic chemicals is sampling. This is crucial to ensure consistently high quality. The sampling of highly active substances up to OEB5 in particular presents manufacturers with major challenges time and again. This is because the substances, which are often delivered in drums with PE liners, can only be sampled using laminar flow systems or with the aid of personal protective equipment (PPE). The container film is also often contaminated, which poses a further risk to employees.
Another challenge is the avoidance of cross-contamination during sampling. Hecht has developed the CPS containment sampling stick for sampling PE liners under containment conditions, which enables samples of critical substances to be taken under containment conditions up to OEB 5. The containment sampling port CPP from Hecht can also be used up to OEB 5. Filling takes place in wide-neck bottles and can be checked visually until the desired fill level is reached. The filled bottle is discharged via the endless film.
The tablet press supplier Fette Compacting has recently turned its attention to testing tablets under containment conditions: With the Checkmaster CM-X tablet tester, Fette is adding a system up to OEB 4 to its range of existing tablet testing devices. The new system tests the produced tablets for the parameters of weight, size, thickness and breaking strength/hardness. The tablet tester can also be conveniently operated via the ergonomic human-machine interface (HMI) of the i-Series tablet presses.
Solutions for big bag handling under containment conditions
In practice, raw materials and products are often packed in flexible bulk packaging - so-called big bags. In big bag emptying and filling processes, two points are critical for maintaining containment: the connection of the big bag inliner to the station and the container change. In the containment system from mechanical engineering company Engelsmann, the inliner is firmly connected to the connection system via a lowerable sealing disc and an integrated inflatable seal. To minimise operating errors, the system is completed by an automatic control system that guides the operator clearly and intuitively through the individual process steps.
The containment film technology from Novindustra is used for dust-free and contamination-free filling and emptying of highly toxic products (up to OEB 5) into flexible containers, in particular big bags with in-liners. In combination with the Vibro-Dos 200 vibratory dosing flap, high requirements for dust-free, precise and user-friendly filling of highly toxic products into big bags with aluminium-laminated in-liners are met.
Rubitec recently presented a solution for filling big bags under containment. The dosing head is decoupled from the big bag frame and the docking head (SmartDock) so that weighing can take place as accurately as possible. A purely pneumatic control system can therefore also be used for big bag filling. As soon as dosing is required, the manufacturer uses a PLC. Big bag filling can also be combined with drum filling. The system is suitable for requirements from OEB 1 to OEB 6 as well as ATEX areas.
Hecht has developed the Easy Port type CFE-K-EC system for emptying drums under containment requirements up to OEB 5. The new EC port of the Easy Connect family allows drums to be exchanged much more easily and without consumables. With the help of the tilting device for drums, they can be docked effortlessly. The products supplied in drums are additionally wrapped in film, also known as an outer liner (secondary liner), for operator and product protection.
