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Changing production strategies: New challenges in sterile filling

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Sieghard Schuchmann, Managing Director — OPTIMA pharma, elaborates on the new system concepts for dosing and packaging processes, which have been developed to meet current market requirements

Sieghard Schuchmann

Increased flexibility represents nothing less than a paradigm shift in the pharmaceuticals industry. As part of this transition, complete production facilities for new drugs are being realised or redesigned for maximum flexibility. What isn’t changing, however, are the high standards for product quality and patient safety, which must continue to be achieved as (cost-) efficiently as possible. New system concepts for dosing and packaging processes have been developed to meet the new market requirements.

Modular machine engineering

There is a fundamental difference between producing blockbuster drugs and small batches of niche products, as is typical for biopharmaceuticals. Of key importance in this scenario are the filling and packaging processes, which also play an important role in successful flexibilisation strategies. But it takes a diverse range of updated technologies and new system types to achieve something as “simple” as flexibility.

Most system concepts have not been developed with frequent format and product changes in mind. The filling and packaging equipment in facilities of the future need to be able to convert to new products in a simple, fast and reliable manner, especially considering that machine downtime is a critical factor in cost-effective manufacturing.

Making pharma machinery more modular and flexible is essential to a multi-product manufacturing strategy. Modularisation is the answer for projects where it is initially not clear what formulation will be used for a pharma or what quantities will be produced.

Even more time and cost savings can be achieved if custom solutions do not need to be developed. Modular machine engineering is possible in numerous applications, making faster and more inexpensive production possible.

Optima pharma’s INOVA SV 125 machine model has recently been refined into a modular machine platform. It is compatible with the four most common filling systems: rotary piston pumps, peristaltic pumps, mass flow and time pressure systems. Furthermore, the SV machine type has been optimised for processing vials, prefilled syringes and cartridges

Modular systems can be easily extended and added to enhance functionality and increase output. This means the INOVA SV 125 can first be set up with two filling points and then later expanded to 10, which corresponds to an output of max. 20,000 containers/ hour. The same holds true for functionality, which can be modified or extended depending on the pharma classes and container types to be processed.

Variable functions and output

The new OPTIMA H4-10 presented this year at Interphex in the US and Achema in Frankfurt goes a step further. Its design is as flexible as the INOVA SV and it can accommodate the same filling systems.

The OPTIMA H4-10, however, is also able to integrate a standardised, space- saving robot in the filling machine section to remove the tyvek wrappers from the tubs. The standardised machine base also makes it much easier to set up any kind of containment device type, including isolators, CRABs and ORABs. Project execution is considerably simplified thanks to pre-defined connections and pre-production of standardised components.

The transport system in the OPTIMA H4-10 originates from a high- output machine. It has been mechanically simplified yet boasts the same gentle handling without containers coming into contact with one another. The output range is higher than that of the INOVA SV125, 24,000 containers/ hour are processed at 10 positions, but can be increased to 36,000 containers/ hour. Filling formats range from 0.5 to 50 ml.

Overall, this means the OPTIMA H4-10 combines the technology and design of high-performance machines in a modular, cost-effective model. The high-performance INOVA H6-10 and H10-16 machines likewise come with flexible options.

The INOVA 125 and OPTIMA H4-10 feature the following options:

  • Manual, semi-automatic or automatic unpacking
  • Manual, semi-automatic or robot removal of tyvek wrappers
  • Filling and closing with or without vacuum
  • Syringe assembly, including if needed insertion of plungers, attachment of finger flanges, backstop locks and safety devices
  • Optical and sensor inspection systems
  • Labeler for identification and track and trace systems
  • In-process control
  • Barrier systems: isolators, O-RABSs and C-RABS can be used

The next step: Multiuse fillers

Optima pharma is pleased to expand its range of modular machine platforms with the new multiuse filler series. The focus is on three areas of application with a high demand for flexibility:

  • Clinical studies, laboratory filling
  • Production Lines
  • Personalised medicine

Superior flexibility is a fundamental feature of all multiuse fillers. The series includes base versions designed for either processing of nested containers or bulk processing. They take into consideration key aspects such as maximum utilisation of available product quantities, fast format changeovers and production scalability.

Single-use technologies

20150930ep22A major advance in multiproduct manufacturing has been the introduction of single-use technologies. Peristaltic pumps and single-use product supply lines for filling and dosing are indispensable in many modern biopharma applications.

For frequent format and product changeovers, they help reduce costs and minimise cross-contamination risks.

Optima pharma recognised the importance of this development early on and developed its own peristaltic pumps for the product portfolio. Filling accuracy is of key importance in this area and is controlled by special algorithms that today are an integral part of the company’s extensive wealth of expertise.

Maximisation of product yield, new isolator technology and new approaches to freeze drying also reflect the new demands on system equipment. As a turnkey supplier, OPTIMA pharma can supply all of the above mentioned solutions.

Quick product changeover

It is often tiny details in a system that makes the difference between cost-effective and uneconomical production. An example of intelligent integration of a disposable product path. To allow for quick format changes, the hose pumps in an isolator-equipped system were located outside the protected area. Sterility when changing disposable materials is maintained thanks to the RTP port and the beta bag. Format changeovers of all parts in contact with product in this complex filling and closing system can be completed in just 15 minutes.

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