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Pharmaceutical Manufacturing and Packing Sourcer

One Use, One Solution


In almost all processes – from upstream to downstream in clean-up or storage – there are now suppliers of disposable products who are successfully placing their products on the market.The demands on these products are clear: the final user is aiming to reduce the cleaning and sterilisation processes. Moreover, the aim is to increase the flexibility of production and significantly reduce the risk of cross-contamination.

As a rule, the user receives these systems already configured and gamma sterilised, and thus ready to use. Compared with the traditional design, the space required in the manufacturing sector is reduced through this concept. The pharmacist can therefore store sets for many years without needing to transport entire assembly groups for sterilisation or cleaning.

However, if we consider the expanding branch of biopharmaceutical disposables in greater detail, it is clear that no standard solution is yet to be found in the area of final filling, and in particular when it comes to disposable filling needles. Indeed, there are only a select few suppliers who have dealt with this subject. For this reason, end-users still mostly rely on traditional solutions. Apart from distribution systems (stainless steel ‘rakes’), this especially applies to multi-use filling needles. Among other things, the main reason is that, because a highly specialised application is concerned, all risks must be minimised where possible. For this application, the product is filtered in sterile conditions and subsequently filled into the final container. Correspondingly, high standards have been set for this final step in the process.

Specifications

By no means must a single-use solution jeopardise the purity of the final product.Otherwise the use of disposable filling needles would be grossly negligent and clearly not permissible by regulatory standards. In addition, filling accuracy (particularly in the case of small volumes) plays a decisive role on account of the monetary value of the active substances. Another prerequisite for a single-use needle is that a transfer hose can be connected to the needle safely and tightly.The pressure requirements in this step are not very high, but nevertheless the connection should work without cable ties.

The demands presented for such a solution also produces several challenges for potential suppliers. Firstly, the material used for a disposable filling needle has to have sufficient hardness in order to ensure the stability of the needle. If this is not the case, the tube will move during rising and lowering. This in turn leads to inaccuracies or even to the medium being squirted out of the container.Moreover, the material has to be procured and processed inexpensively in order to make a single use sensible.These facts seem to indicate that only polymers can be used.

Secondly, during the production of the needle, one has to ensure that no particles can get inside.Any contamination by disposable polymer needles is not acceptable.Thirdly, a disposable needle should only be minimally deformed, if at all. In order to ensure that the container can be penetrated, only a certain circumference per bottle neck can be used to warrant clean filling.

A fourth consideration when building a single-use tube in a set is to ensure that the polymer material can be gamma sterilised. In addition, it is advantageous if the needle material can be autoclaved as well. In particular, if the user does not use a completely disposable system, the needle has to withstand vapour sterilisation of at least 121ºC without changing chemically or mechanically.

The fifth point is that, as already indicated, a suitable means of connection for a hose has to be provided.At the same time the holder has to be designed in such a way that the needle can be attached in the filling line. In an ideal scenario, this receptacle should be so flexible that the needle can be attached universally in any filling device.

Finally, the inside diameter of the polymer needle has to coincide with that of a stainless steel needle in order to guarantee filling accuracy.This, however, requires that the disposable tube can keep very tight tolerances. If all these requirements are met by the disposable version, only the material of the disposable needle has to be safe with regard to regulatory aspects. Relevant standards of the FDA, USP or the European pharmacopoeia have to be observed.

If this aspect has been cleared, a massive advantage for production is ensured. Filling needles made of a regulatoryapproved polymer material increase efficiency considerably. Similar to the systems already existing for other steps, prefabricated, gamma-sterilised filling assemblies can be included in the filling system itself, and manufacturing staff would only have to connect it up.These assembly groups can be designed individually to suit the conditions of the company and can include all required components, such as hoses, bags, filters, distributing connectors and filling needles.On account of such systems, the cleaning processes and vapour sterilisation are no longer required in this area. Consequently, no validation has to be carried out for these steps as the prefabricated systems are only used once. In addition, manual fabrication by the enduser is not required any more either.This fact does not only save costs, but it also eliminates the risk of faults during the assembly. Another advantage is also that no water for injection (WFI) has to be used in the manufacturing process. Today’s multi-use systems have to be flushed with WFI after every batch. Given the new method, the flushing process itself (including the necessary equipment), as well as the outlay for providing the WFI, is no longer required. The disposable concept is a distinctly more environmentally-friendly process (despite the disposal of the sets after each batch) than the reusable systems.

Conclusion

Independently of the range of disposable systems that has been implemented individually, single-use filling needles minimise the risk of crosscontamination across the board. As the efficacy of the filled media is further increasing and as there is a tendency of reducing batch sizes, a disposable needle offers an effective approach to minimise risks. In case of contract production in particular, disposables permit a fast change and qualification of new productions of substances.The introduction of a single-use filling needle is a further step towards converting the biopharmaceutical production process completely to an efficient and safe disposable concept.


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Benedikt Knoch is Product Manager in the Business Team, Marketing and Sales, within the strategic Extrusion/Tubing business unit of RAUMEDIC AG. Within this role, he takes care of RAUMEDIC’s products that are used in pharmaceutical production, such as silicone or thermoplastic tubing, molded parts or fully sterilised assemblies. Before he started at RAUMEDIC in 2009 he studied business administration with the focus on marketing and sales. In parallel he worked for diverse industrial enterprises including Bosch Thermotechnology and ZF Sachs.
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