Case Studies (copy 10)

Case Study: HECHT Containment Sampling Stick CPS

To grant, document and ensure product quality is a crucial topic in all industries. Thereby the aim is to ensure that chemical products, drugs, medication and food are always of the same high quality.

One keyword among other things: Health aspects for end consumers. Continuous sampling and product analyses are therefore essential in order to immediately recognize and react accordingly. Besides the indispensable incoming goods inspection of raw materials, excipients and active substances in the pharmaceutical sector, the In-process control (IPC) of semi-finished products play an equally significant role. On the one hand those samples are used for the analytical quality control, on the other hand they serve as provision patterns to ensure the complete traceability of finished batches. Especially highly active substances up to OEB5 are a particular recurring challenge for manufacturers: The delivered raw materials that often come in drums with PE-liners can only be sampled with laminar flow systems and/or with an elevated level of protective operator equipment. Contamination of the product liner often leads to further problems as well. A hazard due to a half-open container is therefore not completely avoidable.

Two key challenges

The introduction of new products and the expansion of the production range come with new hurdles. If different toxic and expensive substances need to be sampled in a specific quantity and regularity, another challenge arises. Cross-contamination must be completely avoided at any time. After all, these are very critical pharmaceuticals. Long cleaning periods and complex procedures mostly slow down the production process. In addition, the distribution of incoming goods throughout a complete production campus are an additional challenge. Only in this case should hundreds of thousands of euros be invested in quality control and sampling, but the budget is seldom to be provided. This is a concern that a well-known international manufacturer of various medicines has addressed to HECHT Technologie.

In close cooperation with the pharmaceutical company a completely new system for the sampling of PE-liners under Containment conditions has been developed. The brand-new HECHT Containment Sampling Stick CPS (patent pending) enables sampling of critical materials under highest Containment conditions up to OEB5 according to current SMEPAC guidelines. The system represents a refinement of the well-known lance technique in the sampling process by eliminating the weak points such as sealing after sampling or secondary Containment.

HECHT Containment Sampling Stick CPS

This new, mobile, and cost-effective solution with transport trolley allows sampling in just a few steps. The disposable system ensures safe and simple sampling of toxic, expensive, or sensitive products. A resource-saving process with lance technology reduces the investment costs for additional Containment and ensures avoidance of cross-contamination.

Functionality

At first the Containment Sampling Stick is positioned in the respective positioning- and vacuum unit. It is important to make sure that the liner does not form any folds or wrinkles at the area to be sampled as this would be a hindrance in the further process. The positioning of the vacuum unit on the bin can be done after removing the protective foil of the CPS. After switching on the vacuum unit, the sampling stick is correctly positioned. The vacuum unit can now be removed and be dropped in the respective mount. Following, the sampling process starts by using the expandable lance. For this purpose, the liner tube of the stick as well as the product liner is pierced and with the help of the lance a sample can be taken.

The additional liner tube attached to the vacuum unit prevents an open bin even when the lance is retracted again. After the sampling process the remaining liner of the CPS is welded, therefore the bin stays permanently closed. Through a second welding process the sample is separated from the stick and is completely enclosed in a foil tube ready for transfer to the laboratory or storage.

Conclusion

A sampling process in less than two minutes is a massive time saver. In addition, in this specific project a costly PSA and the investment in expensive additional process equipment such as laminar flow units or wastewater treatment equipment for several hundred thousand euros could be avoided.

Ensuring the Containment up to OEB5 and the and the proven avoidance of cross-contamination have made this possible. Due to the mobility of the transport trolley the system can be installed at various locations on the production site via Plug and Play.

HECHT Containment Samling Port CPP

In order to also be able to forward samples in a closed way without using intermediate containers during the various process steps or in closed production chains, the new HECHT CPP sampling port is used for sampling of critical substances under Containment conditions up to OEB5.
The sample is filled into wide-mouth bottles and can be visually checked until the desired filling

level is reached. The filled bottle is removed via the endless liner. At least 50 bottles can be filled per liner package. A new liner package can be connected under contained conditions by means of double-O-ring technology. Optionally, a WIP lance can be obtained for cleaning.

The Containment Sample Port can be easily combined with all common Hecht samplers like the slide samplers or the screw samplers.

 

HECHT Containment Sampling Port CPP
welding
HECHT CPS
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