Handling of products with high containment requirements in the production of API

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Handling products with high containment requirements in API and drug manufacturing

Products in the pharmaceutical industry are highly active and therefore increasingly hazardous. For many of these active ingredients, a limit of OEB (Occupational Exposure Band) 5 is mandatory to effectively protect personnel.  This basically means that environmental contamination should not exceed OEL (Occupational Exposure Level) < 1 µg/m3.

To clarify, if one multiplies the spatial volume by the size of the Empire State Building, the amount of dust will be less than 1/20 of a teaspoon to ensure the OEL. Plant Partner's containment pyramid provides adequate assistance in classifying commodities based on OEB and OEL.

Suppliers or other participating parties in previous steps often fill ingredients in drums. This facilitates transportation. However, the question is how drums can be unloaded without contact between product and operator. For the individual planning unit, the environment, such as ceiling height, must be taken into account! 

Plant Partner can solve these problems: Therefore, two systems guarantee a high level of containment and individual specifications for each customer! 

 

Weightless...

For emptying the containers, users can choose from different systems. Powders delivered in drums are additionally packed in two films (called liners) to protect the product and the user. Depending on the plant operator's structural conditions, the emptying process can be done by gravity combined with a tilting device or by means of a suction lance. 

 

Gravity combined with a tilting device: In this case, the vessel is lifted by a special lifting system and coupled to the connection port at the rear of the glove box. In the initial position, the remaining liner closes the glove box. 

The operator attaches the outer liner tube to the double-ring port of the isolator.

Next, the operator engages the remaining gloved liner in the isolator. 

The clamping ring is pulled to the outer slot where the remaining liner was located. 

The barrel opening is now connected to the isolator. 

 

Inside the isolator, one can now open the inner liner and discharge the product with gloves under high containment. Then the bulk material can move through the glove box

to the next process step by gravity. Alternatively, a suction device can be placed at the bottom of the hopper to integrate downstream vacuum transport. 

After unloading, the film tube is closed with a double locking system. This double locking system prevents the insulator and product from leaking.  The cycle can restart and a new barrel can be unloaded.... or with a suction lance

 

In case of limited space or control

Now the drum is connected and the powder can be sucked out of the drum under vacuum using the suction lance. The linear guidance of the suction lance supports easy operation during unloading. After the drum is empty, the residue of the previous liner can be discharged into the drum. Once the outer liner is detached, the drum is closed with the double closure technology. 

 

The empty drum can now be removed and a new cycle can be started.

Both systems are suitable for unloading in high containment due to their hygienic construction. The closed transport is made possible on the one hand by gravity in the case of multiple layer systems, and on the other hand by pneumatic transport. 

The high conveying capacity is easily handled by the ProClean Conveyor PCC developed by Plant partner. This ensures high transport capacities over long transport distances and guarantees safe transport of explosive or toxic substances. In addition, the environment is dust and dirt free.

Economical vacuum conveying

At first glance, the PCC differs very little from conventional pneumatic conveyors that operate with overpressure or underpressure. The main difference between conventional pneumatic conveyors and the PCC is the filter technology used. PCC's high-performance ring filter system offers significant advantages. 

Most conventional methods operate through blown supply. Therefore, a large amount of conveying air is required to transport a relatively small amount of product. Therefore, huge filter surfaces are required. The ProClean Conveyor PCC works by stitch conveying. Less conveying air is required. Thus, the PCC offers a compact solution with a small and durable filter surface. 

Filters adapted to production

With FDA-compliant ring filtration technology, the filter body acts as an extension of the knock-out vessel. A major advantage of the unique hygienic design and construction is the placement of the connections on top of the housing lid. The vacuum and compressed air units are mounted sideways on the unit and do not need to be disassembled to change filters or perform cleaning or maintenance processes. 

 

Thanks to its compact design, the PCC takes up little space and can be equipped with different filter types. Further advantages: Operating parameters such as transport or cleaning times are easily adjustable. The collection vessels can be loaded under both overpressure and underpressure. 

More information:

Want to know more about; containment, bulk handling, process equipment, single use technology, sampling or components? 

Visit the website of the BeNeLux agent https://plantpartner.nl/ for more information, projects and services. For more information or a demonstration send an e-mail to [email protected] or call us at 085-0600 670.