Keep an eye on the future

Pharmaceutical companies should 'future-proof' inspection solutions now rather than be caught out by EU Legislation, warns Alan Johnson of Loma Systems

With operational efficiency and pharmaceutical safety increasingly under the spotlight, pharmaceutical manufacturers have invested heavily in end-of-line inspection equipment over the past decade.In the meantime, the EU has also turned its focus to industrial equipment standards as part of its overall objective to harmonise legislation across Europe - and automatic weighing equipment is no exception. A move to a single European Measuring Instruments Directive may be just around the corner, so manufacturers should have this firmly on their radar in order to be fully prepared.

The decision to purchase checkweighing equipment may originally have been based on 'local' requirements, but with the consolidation of the pharmaceutical industry, this is increasingly a decision of pan European or even global importance. Purchasing equipment that conforms to the European standard is therefore essential for 'future-proofing' the production line.

The checkweigher market is a prime example of how European countries are harmonising standards. Until recently, there were 13 national approvals in the EU required for automatic weighing equipment, with considerable variations in standards.

This was a barrier to trade, exacerbated still further by language and cultural considerations of the approvals process. However, the intergovernmental organisation OIML (Organisation International de Metrologie Legale) has created the R51 standard as the certificate of conformity recognised across Europe for automatic weighing equipment.

Based on this, the European Commission has also drafted The Measuring Instruments Directive (MID), which is currently being discussed by the European Commission. Manufacturers of checkweighers therefore have the opportunity to secure type approval for their equipment in order to sell throughout the European Union. At this stage no firm decisions have been made as to whether this type approval will become mandatory for checkweighers in the UK, but the UK, Sweden and Greece are the only countries where the standard is optional.

lengthy process

This means that equipment suppliers based in these countries without approval will have trade severely restricted elsewhere in Europe, unless they gain R51 approval or go through a lengthy process of obtaining individual national approvals. This can be achieved in the UK by working with the National Weights and Measures Laboratory (NWML) in Teddington.

Manufacturers may question the fact that they should be concerned about whether equipment suppliers have achieved European approval, but there are in fact considerable benefits. For example, the assessment process at NWML ensures that checkweighers cannot be used fraudulently.

The certificate also provides security that the system is robust and accurate, because a rating is established by rigorous testing in an environmental chamber, designed to simulate extreme production conditions.

Furthermore, there is a lower risk of downtime for pharmaceutical manufacturers who purchase these systems, because approved equipment needs to meet stringent quality standards. Under current UK legislation, any company is free to design a machine, call it a checkweigher and put it on the market, without any guarantee that it will function correctly.

Common faults on the production line could include weight drift, not computing statistics correctly or giving false readings due to external influences.

a step ahead

The R51 standard provides a benchmark against competitor systems. The type approval process also forces businesses to undertake a thorough review of components and work towards better systems overall. Loma, for example, worked closely with sister company Hottinger Baldwin Messtechnik on its new AS Range. The result was the development of a new high performance component, which enables the checkweigher to handle products at the highest line rates without degradation of performance.

Johnson concludes: 'Manufacturers would be wrong to assume that approved machinery costs more to build, and is automatically more expensive to buy. The approvals process can be resource intensive and technically challenging, but often improves overall product quality and teaches valuable lessons for future new product development work. 'It is better to be a step ahead than to wait for the doors to slam shut in years to come.'