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Pharmaceutical and biopharma manufacturing facilities are expected to comply with Good Manufacturing Practice (GMP) to minimize risk and ensure the quality of final products. A related and equally important requirement is maintaining personnel safety
in the workplace. Noise and Vibration exposure are areas of Industrial Hygiene and Occupational Safety that are often a significant contributor to worker health and safety, but also can have a significant impact on the worker’s quality of life.
OHSA, ISO, NIOSH, and ACGIH as well as many other country-specific guidelines outline the right measurement tools, daily dose limits, and deployment of routine testing practices to understand whether employees are being exposed to too much noise and
vibration.
As in any other industry, noise-induced hearing loss and mitigating risk in workplace environments are a concern in the pharm, biopharm, CRO, and API manufacturing processes. Routine noise testing is a foundation for deployment of hearing conservation programs and reducing noise exposure in the high-risk areas can reduce stress, improve communication, and improve overall health and well-being for workers. Noise is regulated in most developed countries around the globe and even in many emerging economies. While worker vibration exposure regulations are common in some parts of the globe – particularly in Europe – many other developed or developing countries have not instituted formal compliance requirements. Vibration exposure does, however, pose a significant risk to employers and employees and has surfaced as a major concern among safety professionals.
There are several areas and activities in pharmaceutical manufacturing with potential to cause unsafe noise levels for workers. Loud environments are common both in manufacturing and packaging areas.
Common machinery that can present noise hazards
Common, and perhaps unexpected, sources of dangerous noise levels are the use of compressed air for cleaning and the bleeding of various types of tanks. Although these activities are short in duration, the noise level generated can be so high that exposure for a short period of time can exceed allowable noise dose.
If employees experience a temporary threshold shift in hearing level after the workday, often exhibit a need to raise their voice to talk to someone nearby, or show signs of hearing difficulties, a noise study should be considered. It's best practice to have good data to get a baseline noise measurement in your facility with particular understanding of whether there have been changes to the worker’s environment or various tasks which impact to an individual’s exposure in a given role or roles. Most guidance also requires that any time a new piece of equipment is installed, engineering controls deployed, or manufacturing floor designs change, new noise assessments are conducted and hearing conservation plans revised. Based on exposure levels, hearing protection zones are determined as well as the types of hearing protection required. For high-risk areas and for risk mitigation it is then common for an employee to participate a hearing conservation program with routine auditory exams.
Measuring noise in the workplace can start with the simple step of making walk-around measurements with a Sound Level Meter that has been field calibrated in the environment just before the measurement. If this measurement indicates high noise levels, a plant noise survey (or noise/sound map) is created. These vary from simple diagrams on graph paper to sophisticated noise maps generated by mapping software to create a more formal assessment of equipment, noise magnitude, and potential reflected or absorbed noise in an area. Measuring individual employees’ exposure for a full work shift using a noise dosimeter will give the clearest picture of an individual’s daily noise exposure and risk. Upon collection of these two pieces of information, decisions can be made regarding improved engineering controls (lower noise emissions, installing sound absorption material, enclosing areas with noise reducing housings, etc.) as well as what types of proper hearing protection (NRR: Noise Reduction Rating) is required in areas where protection must be worn. Frequency or “pitch” of the noise also has an impact on the types of materials used or types of hearing protection used. A standard 1/1 octave band (common on most devices) is sufficient for noise dosimetry, but using a sound level meter with 1/3 octave bands can have a benefit in noise mapping.
Who is responsible for measuring workplace noise? Ultimately it is often the OHS leader who in turn has a staff industrial hygienist who hold a CIH or CSP. Industrial hygiene consultants may be called upon by smaller companies who may not have resources to perform a noise study – or even by larger pharma, biopharma, and CRO organizations that prefer a third party perform the study and provide reported feedback and offer consultative solutions to any problem areas. In the end, however, it is incumbent on the employer to insure a safe work environment with particular attention to worker hearing loss.