A minor incident at one of Schering-Plough's manufacturing sites in County Wicklow, Ireland, was the starting point of a training project that has far-reaching and long-term implications for the site and the engineers working there. David Holton explains.

Schering-Plough is an American owned multi-national pharmaceutical, veterinary and healthcare corporation. It operates plants in 24 different countries, including three in Ireland, and employs over 20 000 people worldwide. The 54-acre Rathdrum site is located in County Wicklow on what was originally an old hunting estate purchased by Schering-Plough in 1981, where it has expanded to its current size employing over 350 people.
A wide variety of active pharmaceutical ingredients (APIs) are processed at the Rathdrum Site, which includes drugs for human and veterinary use, the most important of which is Clarytin. This is a non-sedating antihistamine for the treatment of hay fever and is currently the world's number one seller for this type of ailment.
Thirty-five finished products and 85 intermediates are currently manufactured in anything from two to ten steps. The production processes are similar, comprising of basic operations such as reactions, refluxing, crystallisations, centrifuging and drying.

What is a hazardous area?

Manufacturers, plants and sites have to classify their hazardous areas and restrict and limit their use of equipment in those areas. The dangers of siting electrical apparatus and equipment in areas where explosive mixtures of flammable materials and air could occur are covered by the ATEX 137 directive.
An issue with a contractor connected with quality of workmanship led Schering-Plough to an internal decision to re-examine the standard of training of all site personnel, with a particular focus on contractors.
While the incident did not impact in any way on safety, the resulting investigation showed that many of the contracted engineers did not have the depth of training in the use and purchase of electrical equipment in hazardous area that Schering-Plough felt would optimise the quality and safety aspects of work practice on site.
It was decided that the situation would be rectified as soon as possible by sourcing appropriate training, and the responsibility for this lay with the site's systems engineer Karl Lawler.
Lawler has been with Schering-Plough at Rathdrum site for five years and comes from an electrical/control systems background. He has worked in the pharmaceutical, dairy and brewery industries. In his role as systems engineer, Lawler manages a small group of engineers who are responsible for manufacturing and utility control systems on the site. This includes security, the telephone system and the provision of electrical expertise to site project engineers on areas such as electrical systems and hazardous area equipment.
His first move was to contact several companies offering a training service for hazardous areas. He eventually decided to appoint Sira Test and Certification, for the following reasons:
v The Rathdrum site had used Sira before to conduct a full site survey for classification of hazardous areas in 1994 because the existing area classification produced was incomplete and did not reflect the modifications which had occurred to the plant over many years.
v The company responded very quickly and was able to offer course delivery within a few weeks of the request coming from Schering-Plough. This was a clear difference in service provision from other suppliers and meant the high priority given to the project by Schering-Plough's management team could be effectively met.
v Courses could be changed to meet the specific training requirements of the prospective delegates.
v All the staff in the department had received training from Sira before and the feedback from them had been very positive.
v Lawler receives regular updates from the company of courses on offer and so he was aware that it provided what he was looking for.
v Much of the equipment used on the site is certified by the company.

Non-standard courses

An existing training course was adapted to meet Schering-Plough's needs. The company also decided that it was much more convenient and cost-effective to deliver on-site training to employed site engineers, contract engineers and to contractors - although the groups had differing needs and constraints.
For contractors who, due to time constraints, were unable to attend a three-day course, a two-day course was devised. This involved removing some of the theory and academic material and replacing it with more practical and hands-on information that is directly relevant and useful to contractors.

This included topics such as equipment marking, flameproof equipment (Ex d), intrinsic safety (Ex i) and increased safety (Ex e), maintenance and repair. All contractors participating in the course were assessed to ensure that they had attained a high level of competency on all course subjects prior to returning to work on the Schering Plough site.
For engineering staff employed within the department, the course was modified to last one day, with the contents adjusted accordingly. For example, it was not necessary for them to know about the finer details of electrical equipment installation - since this is already carried out by the systems group - but they learnt the broader implications of hazardous area equipment such as what to take into account when ordering equipment and how it impacts on the various zones on the Rathdrum site.
A typical hazardous area training course covers:
v Properties of flammable materials.
v Area classification.
v Equipment marking.
v The legal requirements.
v Type of protection: flameproof, IntrinsicSafe, increased safety and pressurised equipment.
Installation.
v Cables and conduit entries.
v Earthing in hazardous areas.
v Maintenance and repair.
v Inspection and testing.
v Electrical equipment for flammable dusts.
"The feedback from course members has been very positive from both site staff and contractors alike, the main points being that it was easy to understand, that it was relevant to their everyday work practice and that it retained interest with the use of controlled explosions and hands-on work - this type of course is notorious within the industry for being a little dry! We have been very pleased with the service and the excellent delivery of training offered in such a short time," noted Lawler.

Benefits of the training

The training has benefited the whole site in several different ways. For one, it has added depth of knowledge across the team in the engineering department, improving both efficiency and use of engineers' time. As it is only a small core team of six engineers, increasing specialist knowledge in hazardous areas and on-site electrical equipment has eased the time pressure on Lawler as systems engineer. Freeing him from some of the day-to-day tasks has enabled him to fulfill more effectively all the other aspects of his role, such as installation issues, project management and planning.
The resulting increase in competence and knowledge levels of the whole department has ensured that zones are not compromised when placing electrical equipment into them. The Rathdrum site houses six production buildings and a drum store, all classified as Zone 1, meaning all the electrical equipment purchased goes into a Zone 1 area and therefore needs to be appropriately rated. After this training, engineers now have a deeper knowledge of how to specify and purchase electrical equipment for installation into those zoned areas.
Safety issues are of paramount importance to Schering-Plough. Securing hazardous area training that was specifically tailored to meet the needs of the Rathdrum site demonstrates this commitment to good practice and effective risk management to employees, customers, regulatory bodies, investors and all other interested parties.

A processing site such as the Rathdrum unit, which manufactures active ingredients that will be used for human and veterinary pharmaceutical products, is subject to many regulations under various bodies. This addition to the staff training programme demonstrates good practice to these bodies.
An additional benefit to the company is the positive light in which insurance companies view the undertaking of this type of training.
Lawler concluded: "In hindsight the minor incident which sparked off this whole chain of events has been a positive catalyst for Schering-Plough. The importance of ensuring that all personnel are fully trained in the safe use of electrical equipment in hazardous areas is recognised by Schering-Plough. In fact, the company now insists that all contractors and staff who use electrical equipment in hazardous areas have this training. Our experience of Sira and the professional, interesting and uncomplicated manner in which courses are delivered, means I would approach the company first if I needed any of these services in the future."
David Holton is Senior Certification Engineer with Sira. Details of hazardous area classification, equipment marking and employers' obligations under the ATEX directives are all available in one useful wall chart, available free of charge from Sira.

For more information on Hazardous Area Services and to receive a free copy of the wallchart please contact Sira on + 44 (0) 1244 670900, email exhazard@siratc.co.uk or visit the Sira website at www.siraservices.com.