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The good practice guide to pharmaceuticals

Des King reports on manufacturers' quest for industry acceptance

Cutting through the cumbersome regulations set out by the US Food and Drug Authority – and its European counterpart the Medicines Control Agency – validation is essentially concerned with ensuring that machinery, materials and methods employed in the manufacture of pharmaceuticals packaging are at all times fit for purpose.

The USA accounts for an estimated 40% of the global pharmaceuticals market, with Europe following close behind at around 25%, with its attendant packaging valued at e3.4M. Within that level of financial context, validation requirements are clearly far more than just advisory guidelines. If you want to do the business then you have to toe the line.

For David Woolley of Brecon Pharmaceuticals, solid dosage contract packaging specialists, validation is a challenge that he prefers to view as an opportunity.

“We are looking to establish a practical, standardised approach to validation,” he says, “which to the uninitiated might seem to be an issue of enormous technical complexity. By breaking it down into core disciplines such as cleaning, operation, maintenance and calibration, we are creating transparency for ourselves, our suppliers and for our customers.

“Validation should continue throughout the life of the machine to ensure that it continues to perform safely, securely and at optimum levels. This can be as simple as establishing and adhering to a routine for calibration of critical functions such as temperature and pressure, or as complex as software change control when a sophisticated system is upgraded.

“Well-maintained and validated equipment has benefits for the user, the equipment supplier and the customer.

“The establishment and mainten-ance of good practice in the area of validation, such as documented clean-down between batches, has a direct impact on the quality of the finished product and minimises the potential for reject packs.”

It’s an approach to the issue that can generate positive results, as evidenced by the company’s successful co-operation with US drugs manufacturer Eli Lilly in providing the packaging for a product recently introduced into the Japanese market for the treatment of schizophrenia.

Operating to MCA standards as well as the FDA Drug Masterfile, Brecon was, nevertheless, the subject of a thorough Eli Lilly audit prior to being awarded the contract.

Serving over 70 pharmaceuticals and healthcare companies worldwide, Brecon has recently installed a new £0.3M blister packaging line built around a Noack 623 machine offering increased web width and running at twice the speed of previous systems.

Romaco’s Hapa division, based in Zurich, has recently extended its White Line range of in-line printing systems for pharmaceutical packaging through the introduction of the 350, which prints pre-cut carton blanks on demand as an integral part of the packaging operation. The machine offers four-colour process plus lacquer.

Designed to help overcome logistical difficulties associated with packing large numbers of small batches, the 350 is claimed to achieve packaging material cost savings as high as 70% through lower stock-holding, avoidance of materials obsolescence and the capacity to print on-demand.

Hapa’s entire ‘White Line’ range is geared to accommodate validation requirements, producing high-quality UV flexo print and available as in- or off-line solutions for flexible integration with existing equipment.

The 350 is Hapa’s first carton printer capable of four-colour process printing, and is not reliant on reel-fed materials. Maximum output is 360 cartons/min and carton blanks up to 420x500mm can be handled. The 350 also boasts the ability to handle stock up to 600gsm – an increase of 50% over earlier systems.

Hapa has also just launched a digital printing technology for packaging substrates such as foil, paper, PVC/laminates and labels that eliminates the need to laser engrave plates as a separate stage of the origination process.

The Hapa 730 offers high-resolution flexographic print at speeds of over 19m/min, and its secure method of data transfer complies with the stringent validation criteria of the pharmaceutical sector. The system of non-erasable master foils makes for easy validation and the continuous inking process ensures that print quality remains high and absolutely consistent for the entire run.

IMA’s recently introduced Sterifill F200 further establishes its strong position in the aseptic filling field, and is being particularly targeted for drugs processing in aseptic conditions, either in a traditional class 100 area or in isolation technology. Among a number of advantages claimed over traditional filling machines are its ability to operate at 100% IPC of filled weight, and up to 500ml dosing range and vial size.

The machine can be easily qualified and validated, and has been constructed to guarantee a total exposure of machine to laminar flow and to the sterilising agent, typically VHP – vapour phase hydrogen peroxide.

Visitors to Interpack earlier this year will have seen the F200 as part of a complete processing line incorporating a Libra Hydra linear washing machine and a Libra Blue Galaxy sterilisation tunnel.

These are designed according to Good Manufacturing Practice recom-mendations (as issued by regulatory bodies such as the MCA).

Hydra machines are available in a range for the treating of all vials used for the pharmaceutical industry with vial speeds up to 34 000 pieces/hr.

Blue Galaxy is a VHP sterilisation tunnel designed to be inserted in a production line that requires continuous depyrogenation by means of dry heat.

AstraZeneca in Destelbergen Belgium has become the first customer for the recently launched NV2, a versatile new labelling system from Newman.

The labeller is being employed across an extensive range of pharmaceutical products, packaged in many sizes of plastic tubs, glass vials and aluminium aerosols.

The NV2 features a range of options which includes unlabelled container detection and auto-reject with verification.

Newman has also introduced the innovative Series 250 labeller incorporating a single high-capacity cable databus in place of a traditional and invariably bulky and unwieldy wiring loom.

Originally developed for auto-motive and process automation applications, the databus acts as a main ring, enabling sensors and control devices to be connected at any point on the circuit, and communicates at high speed with microprocessor based control systems through standard software.

Specially designed to handle inhaler aerosols, Europack’s pharmaceutical tray loader offers manufacturers reduced labour costs and faster, fully or semi automated product handling.

Typically, product enters the machine in a single file where it is collated into a count of around 207 units. Trays are placed over the collation that is then rotated through 180o to stand the product on its head. Collations are palletised, within the machine frame, using pick and place technology.

Trays then enter a storage unit where the aerosols are checked for valve leakage. This stainless steel Europack machine is capable of handling up to 200 aerosols/min.

What of the future? According to PPMA director Andrew Manly, while the main focus will be on stimulating innovation, developing a clearer understanding of ways in which to meet validation requirements will remain high on the agenda.