Syringe benefits

Andrew Longworth, general manager at Koerber Medipak UK and Ireland, a group dedicated to the supply of packaging systems to the pharmaceutical industry, describes packaging equipment for the growing pre-filled syringe market and the benefits of OEE

The PFS is an attractive presentation for both new and established parenteral pharmaceuticals and vaccines

Andrew Longworth, general manager at Koerber Medipak UK and Ireland, a group dedicated to the supply of packaging systems to the pharmaceutical industry, describes packaging equipment for the growing pre-filled syringe market and the benefits of OEE

The demands of packaging pharmaceutical products are uniquely stringent. Not only is the shelf life measured often in years, but the product is also distributed globally and must be administered in a precisely prescribed way. The packaging must satisfy these and product-specific requirements. It is no surprise therefore that suppliers are specialists in their chosen fields.

The pre-filled syringe (PFS) is an attractive presentation for both new and established parenteral pharmaceuticals and vaccines. It is also becoming the presentation of choice for biotech products. Research by Koerber Medipak indicates that 45% of new approvals are for products with a biotech component and of these 90% are parenteral liquids.

There are two fundamental requirements, determined by use, for PFS packaging. If the product is administered in a cleanroom environment, then the package must be suitable for terminal sterilisation at some point. If, however, it is administered in a general environment, the packaging may be designed for broader criteria - minimum volume for chill chain distribution or compliance for self-administration, for example. While there are no hard and fast rules, the former type tends to suit a thermoformed package and the latter a top-load cartonboard package.

Koerber Medipak is a specialist manufacturer of automatic equipment for the production of both of these package types.

thermoformed packaging

The thermoformed package provides a relatively rigid, flanged tray into which one or more primary product containers are accurately located. The tray may then be lidded with either an impermeable material, such as PET film, or with a proprietary semi-permeable material to facilitate gas sterilisation. The completed trays may then be collated and packed into an end-load carton. The lidding material is usually peelable and a thumb notch is incorporated in the formed tray to provide a tab.

The packaging process is as follows:

Unwind of reel of base material, e.g. PET or PVC

Controlled heating of the material by contact plates

Thermoform of the tray into a mould by means of compressed air and plug assist. A continuous web is formed

Transfer to product infeed group. Product arrives from an upstream machine, for example a labeller, or may arrive in trays. The automatic infeed group collates the products to the format required and places the collations into the formed web

Inspection of the filled web by vision system

Unwind of lidding material and heat seal to the web (if required)

Perforation of the web for separable trays (if required)

Cut out of individual trays

Rejection of defective trays

Transfer to the cartoning machine

Variable data may be applied to the lidding or embossed into the flange of the tray

Last year, Koerber Medipak company MediSeal introduced its latest machine for this application. The CP500 deep-draw thermoformer is designed specifically for products such as PFS, ampoules, devices, etc. The machine offers flexibility, a high degree of automation throughout the process and an attractive price-performance ratio.

Technically, the machine is based on third-generation digital servo drives coupled with a completely modular, balcony construction. The drive system ensures that operating parameters for each package format are optimised and changeovers between these formats simplified to a minimum. The modularity ensures segregation into operating zones.

The CP500 offers several solutions for connection to a MediSeal end-load cartoner - for example, direct transfer at high speed of trays of single syringes into unit cartons or the stacking transfer of trays of five or 10 ampoules into larger cartons.

According to configuration, the CP500 has a maximum output of 500 trays per minute and can produce trays measuring up to 315 x 230mm and up to 45mm deep.

top-load carton packaging

The top-load carton readily satisfies the multiple requirements of a PFS package and has supported the rapid growth of the PFS for some categories of product.

The package must enable rapid access to each of the products it contains and must remain intact until the last of the products has been removed. The printing of the package must clearly present essential product information. The package may also include features that promote dosage compliance.

The package may be designed for a minimum volume with respect to its contents, which is of particular relevance to controlled temperature distribution. Minimised package volume also benefits storage immediately prior to use - for example, in a hospital pharmacy.

The package is formed from two pieces of pre-cut cartonboard and is produced on a single, fully automatic machine. The process is as follows:

A magazine-fed, printed, die-cut flat blank is folded and glued to form the outer carton

A magazine-fed, die-cut blank forms the internal, product-specific matrix of the carton. This is glued in place inside the formed outer carton

The carton, with top held open, is transferred to the product infeed zone of the machine where the product is collated and located into the matrix

A vision system verifies that the carton has been correctly loaded

The package insert(s) are fed and placed into the carton, again with verification

The carton is folded and closed, either with a simple tuck-in or with a glue closure

Variable data is applied and verified

The finished carton package is discharged from the machine; defective packages are rejected

Koerber Medipak company Dividella is a manufacturer of top-load cartoning machines. The NT804, introduced three years ago, finds wide application for PFS.

This machine has a standard output of 80 cartons per minute, but with the "triple mode" system, gives outputs of 240 unit cartons per minute. The machine is again fully modular in construction enabling total segregation of the product-feeding zone from the up- and down-stream zones. The technology of the machine facilitates a "first carton - good carton" changeover philosophy. In standard configuration, the NT804 can accommodate a maximum carton size of 240 x 170 x 70mm.

Working with sister company Rondo, a supplier of folding cartons to the pharma-ceutical industry, Koerber Medipak offers a complete packaging development process to ensure that the potentially complex design brief for the package is fully met.

pursuit of oee

The pursuit of overall equipment effectiveness (OEE) is, in essence, to maximise the utilisation of complex production assets.

A typical automatic syringe packaging line comprises a number of linked machines, each with its own constraints - a simple example would be a plunger assembly machine feeding to labeller feeding to thermoformer, or top-load cartoner feeding to end-of-line casing and palletising. The pursuit of OEE for the line requires analysis of the performance of each of these machines. These performance constraints fall into three general categories:

1. The production mix, average batch size, number of changeovers

2. Operational methods and procedures

3. Machine technologies

A machine manufacturer has a significant contribution to make to the first category. Single minute exchange of die (SMED) technologies are well established to facilitate rapid changeovers in an environment of fragmented production runs. However, users continue to press for developments and here the innovative machine builder can bring new solutions. For example, MediSeal Late Stage Customisation technologies - the inter-mediate storage of part of the throughput for subsequent separate customisation to fulfil the smallest orders - are applicable to syringe packaging lines.

In the second category, production managers must address workflow and work organisation.

The machine manufacturer has a fundamental contribution to make in category three. Appropriate selection of machine design technologies will directly enhance uptime of the equipment when running (efficiency) and reduce downtime (availability). Servo drive technologies contribute directly to running efficiency through high levels of reliability and repeatability of function. Modularity and attendant segregation allow access for rapid clearance and cleandown. Both technologies enable the packaging machine to be precisely configured to user requirements.

With the fundamentals in place for enhancing OEE, detailed analysis of operating methods and organisation will reap rewards. The consequence is that cost of ownership of the assets and cost of output can be accurately predicted to give the packaging business a powerful competitive tool.

In summary, the PFS is an effective way of delivering medicines and its use is set to increase. In addition, the pursuit of OEE of automatic packaging lines is fundamental to the competitive performance of the business.

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