Shrinking Lot Sizes and Abundant Data Create Opportunities

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For many pharmaceutical manufacturers, flexible filling and packaging solutions such as the Bosch MHD for aseptic filling of biopharmaceuticals are the preferred choice. With the aid of robotics, different types of packaging can be filled in the isolator. In response to the trend towards smaller and smaller batch sizes, Romaco offers a mid-range line for primary, secondary and tertiary packaging of pharmaceutical solids. "The line is highly flexible, and it is also very rugged and compact," reported Bauernfeind. He argues that the increased expectations for track & trace create the need for packaging designs which offer the same capacity but take up less space.

Gerhard Breu, who is head of the pharmaceutical business at Optima, said that the company will use robotics technology to meet the need for greater flexibility. It is his expectation that "life cycles will become much more dynamic and that new production variants and containers will be frequently added to the portfolios. In response, he intends to market systems with exceptional format flexibility to handle very small lot sizes. Optima presents a suitable solution at Achema featuring multi-use design for variable filling of vials, syringes and cartridges. The system is based on an adjustable transport system which eliminates the need for format sets. Manufacturers of high-cost active ingredients such as ATMPs will undoubtedly welcome solutions which reduce product wastage, for example by using short tubing, 100 % process control and post-dosing on demand.

Andreas Häußner, Marketing Director at the Rommelag Group, is also fully focused on the need to offer customers high flexibility and process reliability. Achema visitors who are looking for flexible packaging solutions capable of producing very low quantities and very small batch sizes at an affordable cost and with built-in traceability should stop by the Rommelag booth. Häußner mentioned a "disposable filling system which we have already used in initial trials aimed at personalized medicine".

Bauernfeind pointed out that the importance of Industry 4.0 differs worldwide. In industrialized countries with high labor costs, Industry 4.0 will soon be very tangible, whereas in emerging markets it is something that is more likely to be relevant in the medium to long term. Suppliers of packaging machines had to be prepared for different scenarios, Bauernfeind said and added that there was no other way for us to offer solutions which meet actual needs.

Single-Use Containment Minimizes Validation Costs

Containment systems and fill & finish are inextricably linked. They protect the operator from high-potency products and vice versa. Single use strategies are also a very effective way of preventing cross-contamination. Pilot solutions which combine containment and single-use design were on display at Achema 2015. In 2018, additional suppliers will exhibit systems which have reached an advanced development stage. However Bauernfeind advised caution: What was needed is close cooperation with pharmaceutical manufacturers to ensure that the systems are tailored to customer needs without costly over-engineering. He cites continuous manufacturing as a way of protecting machine operators from high-potency substances. Pharmaceutical machinery manufacturers should also provide risk analysis advice to customers.

Rommelag's Flecotec system is a bit out of the ordinary. All sampling, weighing, filling and decanting processes can continue as normal. They are literally wrapped up with the aid of a single-use containment system. The entire system is then disposed of. Their solution is to intelligently package the existing process, so there is no need for re-validation.

Bosch takes a different approach, namely washable containment. It is used in a capsule filler for small batches. Product changeover can be done quickly. The manufacturer promises short cleaning times and low water consumption. The machine makes it easy to handle high-potency solid dosage forms. Some market researchers predict double-digit annual growth for HPAPIs (High Potency Active Pharmaceutical Ingredients) over the next five years. For this market segment, Fette Compacting offers reliable containment solutions and Containment Guard, a quality certificate based on a test process which complies with Smepac (Standardized Measurement for Equipment Particulate Airborne Concentrations) guidelines. It documents the OEB level of the containment tableting systems and makes set up easier for customers. They can select the right containment system with greater confidence and reduce the risk of installing a solution which is inadequate or too expensive.

There is also room for innovation in standard isolator technology. Metall+Plastic, which is part of the Optima Group, will exhibit a sterility testing isolator (STISO) which was unveiled for the first time at Interphex in the middle of April 2018. The Stiso is very user-friendly, and the decontamination process has very short cycle times. This is achieved through catalytic air circulation and a special decontamination system which distributes hydrogen peroxide very quickly in droplets that are much smaller than on conventional nebulization systems.

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