Top hygiene in the use of bulk solids.

“Our ProClean standard enables us to meet increased demands in hygiene, safety, reproducibilty and quality.“

ProClean Design

ProClean Design stands for simple to clean, cavity-free and closed systems. This is essential for the manufacture of active substances and medicines.

More Information:

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Top hygiene in the use of bulk solids.

“Our ProClean standard enables us to meet increased demands in hygiene, safety, reproducibilty and quality.“

ProClean Design

ProClean Design stands for simple to clean, cavity-free and closed systems. This is essential for the manufacture of active substances and medicines.

As opposed to liquids, solid particles can be distributed all over a company’s premises by way of the ventilation system, on surfaces or through personal contact by members of staff, if they are not handled professionally. The clean-up procedure that is then required to avoid cross-contamination can not only be extremely difficult but is often impossible. That is why the ProClean Design is so important and should be considered in the early stages of planning machinery. Since the devices and containers are constantly closed, external components are unlikely to be affected; instead, the emphasis is on the design of surfaces that come into contact with the product. The components inside the machine must be cavity-free and easy to clean. A high-quality surface considerably lowers the risk of product deposits and therefore reduces the growth of micro-organisms.

Design of Filling and Discharge Systems

Solids are fed to and from a process. A container filled with the solid is filled into the process device, which is discharged into another container. Suitable filling and discharging systems are necessary to maintain the workplace in a ProClean state.

Packaging for solids:

• Cling-film bags

• Sacks

• Stainless steel drums

• Drums with inliners

• Containers (IBC Intermediate Bulk Containers)

• Big Bags (FIBC Flexible Intermediate Bulk Containers)

HECHT supplies systems for all these containers in order to empty or fill solids under low-dust conditions.

In many cases metering systems determine the transferred quantities precisely.

Containment Systems made by HECHT

Containment describes the process whereby a biological agent (medicine, health-risk factor) or another material is enclosed within a defined space. By “total containment“ we mean the degree of protection accorded to humans and the environment in the pharmaceutical industry, due to which cross-contamination is avoided.

Effective operator protection is achieved by enclosing the product in the area where it is produced, from the very first step in the process until the final packaging. The critical point often occurs whilst transferring the product between the process machinery and the transport containers (various types of containers, drums, sacks or Big-Bags). This involves setting and adhering to OEL-/OEB-categories (Operational Exposure Limit/Band). OEL defines the average degree of concentration (µg/m) of a substance measured for a period of 8 hours in the area in which the operator breathes. For the OEB value (1,2,3,4,5) the toxicology of the material itself is taken into account. The aim is to classify plant machinery so that suitable production units and processes can be selected for a certain product.

Once OEL/OEB values have been set for a new substance (including chemical products), the required technical procedures can be defined and the investment and operating costs can be reduced to a minimum. In the case of extremely hazardous substances, much higher standards are needed than for harmless granulate materials.

Hecht Anlagenbau GmbH has developed systems and containers for transportation that meet all OEL/OEB criteria.

Non-toxic solids (OEB1) can be refilled using open systems and on –site suction.

For slightly toxic solids (OEB1-3) we recommend the SoliValve® closing and metering system that can be integrated inside all commonly used containers.

CMR (carcinogenic, mutagenic and reprotoxic substances) and toxic materials (OEB 3-5) can be refilled safely with the aid of protective film systems.

Isolator systems are implemented for extremely toxic materials (OEB 5 and above).

More Information:

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Attachments

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The Protective Liner System® connects the FIBC to a liner.

Principle of the Protective Liner System®

Centered around the end of the feed tube there is a film carrier with approx. 30 m protective liner. The end of the liner seals off the feed tube. The inliner of the Big-Bag is connected to the protective liner with the aid of a cardboard ring before it is opened, and the liner is transported by the liner carrier. Then the inliner is clamped shut. The hose of cling-liner completely encloses the container outlet. After the discharge, the operator seals it with tape and cuts through the middle of the tape. The feed tube is closed again. The cardboard ring is sealed and disposed of together with the contaminated liner. As a result, the product never comes into contact with the environment. The system also enables the liner carrier to be exchanged without causing contamination.

More Information:

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Attachments

be-sas--i (JPG)

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