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  1. OPTIMA Pharma
4 November 2013

International Experts, Perspectives and Processes

Featuring a series of exciting talks on a range of topics, the 2013 Pharma Forum once again showcased innovations and technological trends in pharmaceutical packaging processes.

Operators themselves reported on how well the machines work in daily practice as well as what advantages and limits they encounter. Another area of focus was project management, an aspect which is essential to successful packaging lines.

Organisers Optima Pharma welcomed international visitors to the event held at company headquarters in Schwäbisch Hall from 25 to 26 September. Visitors were very positive about the opportunity to network at a high professional level.

Use of disposables and integration of peristaltic pumps

Disposables and peristaltic pumps have become the technology of choice in many projects, but they are often not the only option. Several talks were dedicated to this system, frequently also touching on another trend, the flexibilisation of pharmaceutical systems.

Three different filling systems in one line

In terms of flexibilisation of equipment, an attendee reported on a SCF™ syringe line, which uses no less than three different filling systems, one of which is a peristaltic pump. The owner of this line has teamed with Optima Pharma to investigate and document the advantages and disadvantages of the individual filling systems in this line for various drug types. The particle behaviour of disposables has also been examined, along with limits for batch sizes for example.

Projects presented at the Pharma Forum which impleneted two different filling systems generally integrated peristaltic pumps, for example in a system for clinical studies. Another project featured redundant filling systems.

Dual-chamber syringe and robot technology

The more individual the requirements, the more often (flexible) robot technology is used. It was apparent at the Pharma Forum that this technology already plays an important role in processing today.

For example, a specific syringe system with two holes was reported on, which is used to apply a two-component adhesive during surgery. Relatively small numbers of these syringes are produced each year using a packaging system designed specifically for this purpose, in which robots perform handling tasks.

Another example is a robot-aided transport system installed in a tight space. In this application, plasma products must be fed through very close quarters to various freeze dryers already in place.

Regulations and technical solutions

The issue of GMP-compliant processes for capping vials arose multiple times. Annex 1 was thus a recurring theme in the talks. This regulation motivated a company to systematically investigate their closing process for vials – stopper insertion and crimping – in great detail. They explored the question of what exactly leak-tightness means and how to measure such a property. The company developed a special test apparatus based on helium to determine leakage rates. The tests made it possible to find the best combinations of vials and stoppers and to define the parameters for the ‘leak-proof’ stopper position.

Avoiding errors I: use of FMEA in plant planning

One idea, and two different approaches to avoiding errors. The earlier errors are recognised and corrected in projects, the lower the consequential costs. FMEA (Failure Mode and Effects Analysis) is a method of project organisation which helps to minimise risks and achieve maximum machine efficiency from the very beginning.

A key principle of FMEA is the schematic depiction and description of the processes. The starting point for planning should be the zone of the core aseptic ‘filling and closure’ process with its upstream and downstream processes, and not existing room constraints, emphasised one speaker. Process steps are subdivided into input and output. Every process step and even every material which enters or leaves the process is clearly labelled in the schematic.

Avoiding errors II: virtual reality – flow visualisation vs mock-up

Mere vision or already reality? Three-dimensional visualisation techniques are used extensively in pharmaceutical machine construction. At the Pharma Forum, the implementation of 3D technologies in productive machine development was presented. The example involved a 1:1 simulation of the air flows within a barrier-protected area, including the loading of a freeze dryer.

This virtual reality simulation for a customer project was conducted by Optima Pharma in co-operation with the High Performance Computing Center Stuttgart (HLRS). First, two speakers explored the theoretical foundations of the simulation. Later, attendees donned 3D glasses to observe the results on a large screen. The air flows were depicted as ‘strings’ moving through the machine, which made it possible to see exactly where problem zones would or would not arise, along with the speed of the moving air.

Six freeze dryers: potential for savings thanks to co-ordination

While freeze drying is a well-established technology, a project with six identical freeze dryers and multiple technical intricacies is certainly something special. The speaker opened his talk with the quote ‘I have a dream’ (Martin Luther King) to emphasise his ambitious goals. The monoblock freeze dryers with a footprint of 10m² each are served by a single central cooling unit. The dryers are loaded and unloaded via ‘pizza oven’ doors on the front and back.

The automatic, frameless loading and unloading system is installed on rails on the front and rear of the dryers with active RABS. This is also how products are further transported to the capping station. Optimising the CIP cycle is anticipated to generate savings in WFI of approximately €100,000 per year.

An intense exchange of ideas took place between the audience and the speakers. Many topics were explored in more detail during the Q&A sessions following the talks and in personal discussions during breaks. One participant described the event as ‘an all-round success’ and praised ‘the open and technologically-neutral atmosphere’.

The general feedback confirmed this impression. The 2013 Pharma Forum lived up to its reputation as an informative trade event and industry meeting point of international stature.

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