Safety in sampling, big bag handling and product transfer
3/28/2024 Preparation & dosing Article

Safety in sampling, big bag handling and product transfer

The market for hermetically sealed systems is growing. The current GMP and REACH regulations are also fuelling this trend. At POWTECH, numerous suppliers recently presented interesting solutions for handling toxic powders up to OEB 6.

Martin Koch at the Rommelag stand at POWTECH 2023 with single-use solutions Martin Koch explains how single-use solutions work at the Rommelag stand at POWTECH 2023

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.

AZO machine for big bag handling under containment AZO has developed special containment solutions for handling large packaging materials (big bags)
The AGW big bag emptying station from Azo is equipped with a glovebox and minimises dust exposure - it meets the requirements for use in OEB 3 areas. After emptying, the big bag is evacuated and securely closed. AZO has also developed a bag loading station for OEB 3 requirements. This combines operator and product protection. Bags are opened in an airlock chamber that is flooded with nitrogen to minimise environmental influences. Empty bags are disposed of without contamination, and Azo has also developed the eddy current screening machine Containment DA Vario. This is suitable for demanding applications with a high dust content. It enables the safe replacement of the screen basket and dosing screw under containment conditions.

Further developments in single-use film technology

With the Flecotec insulators, Rommelag Flex is focussing on the single-use film technology that has long since been introduced. This combines easy handling with a high level of occupational safety and can be used for many products and applications. The insulators are available in two different versions and the devices can also be customised. The flexible system fulfils all requirements for containment level OEB 5 for highly toxic products.

Rommelag Flex also offers the Material Transfer System MTS based on the Flecotec system. The Flecotec system comprises an innovative filling and unloading process for powders, granules and tablets in which the Flecozip closures are used as a secondary interface. The unique system has been proven to perform in the OEB 5 range and can be realised with up to 15 cycles when used correctly with the Flecozip adapter.

Interfaces and containment flaps

The transition between system components and machines is a neuralgic point in all hermetically sealed systems. Flaps and transfer systems therefore play an important role. With the SafeSeal sealing system, Lugaia enables a safe transfer up to OEB 5 (<1μg/m³). The entire closure system consists of a SafeSeal closure, a pressing tool and a cutting tool and can be supplemented with a protective cap and hanger.

Lugaia TransferBags Lugaia offers so-called TransferBags for the product transfer of small quantities.

Lugaia also offers so-called TransferBags for the transfer of small quantities of product. The standard versions are made from an antistatic or pure PE film, but the bags can also be manufactured from a customised film in the cleanroom on request. This enables a high level of containment (OEB 5) to be achieved with a comparatively low investment.

Novindustra also relies on film systems: These are used for dust-free filling of toxic substances OEB 5 and ensure a high level of personal and product protection. The film systems are easy and reliable to handle and safe to use. The manufacturer also supplies Ex versions in accordance with ATEX.

Part of a machine at the Zermec stand at POWTECH 2023: containment flaps At the stand of containment specialist Zermec at POWTECH 2023, containment flaps were shown that can be used to create connections between different devices and containers.
For product transfer, the ZERMEC Group has the MCV containment flaps in its programme. The company now offers direct sales and service for these. The company offers express deliveries for spare and wear parts within the EU via a newly established warehouse in Germany. In addition to shorter delivery times, customers benefit from fast project planning and realisation of containment solutions and a spare parts and repair service for all MCV flaps supplied. The ZCV containment system includes sizes from DN 50 to DN 250 as well as versions for Atex zones 0/20 inside and 1/21 outside. The valves can be easily dismantled for sterilisation or cleaning.
In the next episode, we will present solutions for dedusting and grinding under containment.


Armin Scheuermann

Armin Scheuermann

Chemical engineer and freelance specialised journalist