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Pharmaceutical Manufacturing and Packing Sourcer

Hidden Dangers

Figures released by the Trades Union Congress (TUC) estimate that diseases resulting from occupational exposure cause the deaths of six times more UK employees than work-related accidents. It often takes years for the symptoms of respiratory diseases and noise-induced hearing loss (NIHL) to appear.

However, because workplace accidents are more immediate and often dramatic, there has been a greater focus on safety and accident prevention, compared to measures to tackle long latency health issues – even though the latter potentially cost employers more, with a greater impact on the workforce in the long run.

It is estimated that around 19,000 people are claiming NIHL disablement benefit in the UK. The figures for occupational respiratory disease are even more concerning: some 12,000 deaths and 13,000 new cases each year. Moreover, a predicted 130,000 people suffer lung or breathing problems as a direct result of their work.

Monitoring Investment

Instruments are available for measuring noise and dust exposure levels at work, and this enables pharma manufacturers to implement a cost-effective monitoring programme to protect not only employee health, but also sustainability and business profitability. As noise and dust exposure carries an inherent risk to the bottom line in terms of lost hours, productivity and, in some cases, compensation claims, it is essential to maintain or increase investment in such monitoring programmes.

While occupational hygienists depend on specialist instruments for their sampling and monitoring programmes, they are also relying on devices such as smartphones. The ability to access email, use apps, take photos and notes, and make phone calls out of the office is very useful. Indeed, taking photos and notes on these devices to incorporate reports alongside data on noise and dust exposure has now become an essential component of a hygienist’s toolkit. Increasingly, manufacturers of specialist monitoring equipment are searching for ways to interface their devices with mobile phones and tablets, to take advantage of this widespread technology.

The pharmaceutical industry faces many of the same occupational health problems as other, perhaps heavier, manufacturing industries. Issues such as the inhalation of dust, vapours and the risk of NIHL carry the same threat, even if the source of the hazards and the complexity of the substances differs. The basic principles of sampling and monitoring for noise and hazardous substances apply, whatever the environment.

Dust and Vapours

The risks of occupational exposure to hazardous substances within the pharma industry are broad. Not only is there the risk of inhaling volatile organic compounds (VOCs) during production from recovery, isolation and extraction activities, but dangers are ever-present during secondary manufacturing – for example, exposure to airborne dusts during tablet manufacture.

In addition, while the UK Health and Safety Executive has established workplace exposure limits for the most common hazardous substances, the complex mix of constituents and active ingredients will have no ‘official’ and ‘safe’ limits set.

Another issue for pharmaceutical manufacturers is that production typically happens in an enclosed area, which means that contaminants can be trapped and continue to circulate. The extraction systems used to exhaust potentially harmful particles must therefore be regularly checked and maintained to preserve good air quality in the work environment.

Risk Assessment

The first step in any monitoring programme is to carry out a site survey and risk assessment to identify potential problems and areas that need further investigation. Using a hand-held dust monitor as part of a survey is the easiest way to do this. The latest of these devices graphically display levels of dust, fumes and aerosols in real-time to enable quick decision-making or corrective action.

However, in terms of individual monitoring and the actual exposure of a worker, the preferred method is to use a personal sampling pump and filter assembly. For simple dust exposure, a gravimetric analysis can be conducted, whereby a sampling pump draws a known volume of air through a pre-weighed glass fibre filter. The fraction of dust – either ‘total inhalable’ or ‘respirable’ – is determined by the sampling head used. ‘Respirable’ dust is the problem particles classified as being below ten microns. These penetrate deep into the lung and lodge there. Larger particles tend to be expelled by the body’s own natural defences. Other filter media is available, such as polyvinyl chloride, methyl-cellulose ester and polytetrafluoroethylene, if speciation and further analysis on the dust is required. For VOCs, a sorbent tube and low flow assembly will be needed.

Personal sampling pumps were first developed over 40 years ago, but technology has inevitably moved on – as have customers’ expectations. Performance is key; having a pump that is able to operate with a variety of filter media throughout the shift length is essential. Of equal importance are features like flow control, to inform the user of the volume extracted, and low pulsation value, which ensures the entire fraction of sample is collected. The newest generation of pumps also guarantee greater wearer acceptance with ergonomic designs, motion sensors and connectivity to view or control, via a mobile device.

Noise Levels

NIHL presents another risk within pharma manufacturing operations. Long-term exposure to vacuum sources, ventilation systems and compressed air in an enclosed environment, without adequate hearing protection, may cause this hearing loss.

Although it is preventable, NIHL remains the largest global cause of occupational disease: in 2007/2008, in the UK alone,21,000 people were suffering from hearing problems brought on by their work. With 22 million employees in Europe and 30 million in the US still exposed to dangerously high noise levels, investing in noise monitoring remains a top priority.

In a similar way to dust assessments, noise surveys can initially be carried out using a hand-held sound level meter to identify areas of risk. Following on from this is personal exposure monitoring, which involves equipping the worker with their own noise dosimeter. This small, unobtrusive device is worn on the shoulder, recording the noise exposure to the individual in real-time. Latest models include Bluetooth connectivity, which enables remote monitoring without needing to disturb the wearer. Features previously only available on advanced hand-held meters – octave band analysis and audio recording, for example – are now in the newest dosimeters.

The Control of Noise at Work Regulations 2005 place a legal responsibility on employers to protect their workers’ hearing from noise at work. The regulations impose more stringent limits on exposure: reducing the maximum exposure level by 5dB (to 80dB); creating more action levels; installing compulsory health surveillance; and altogether introducing tighter hearing protection controls. The most effective way to protect workers from NIHL – and employers from the possibility of a lawsuit – is through regular risk assessment and monitoring.

Preventive Actions

Industrial accidents always draw more attention than occupational health. One only has to view the news coverage generated by the chemical spill at Novartis’ plant in Basel, Switzerland in 2012, in which five contractors were hospitalised. Just as lamentable, however, are the aforementioned TUC figures, which reveal that diseases caused by occupational exposure cause the deaths of six times more employees than work-related accidents.

Unlike workplace accidents, health conditions associated with often prolonged exposure to noise and hazardous substances have a long latency. The health of workers must be well looked after through ongoing, long-term measurement and monitoring of exposure levels and preventive actions to manage the risks – averting permanent health issues many years down the line.

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Andrea Bowen is Technical Product Manager at Casella, a global provider of occupational health and environmental monitoring equipment. She supports the new product development of the company's innovative dust and noise monitoring equipment across all industrial and public sectors. A trained chemist, Andrea’s working career began as a laboratory analyst at BP. She then moved on to product management and business development roles for a number of leading scientific and medical businesses.
Andrea Bowen
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