Pharmaceutical and Medical

Occupational Hygiene

In addition to the hazards presented by other manufacturing industries, the pharmaceutical and medical sector faces specific occupational hygiene issues related to the chemicals it employs. Attention may initially focus on the active pharmaceutical ingredients (API) used in a formulation, many of which might present clear risks to workers.

The other ingredients (excipients) used in the manufacture of pharmaceutical products, such as binders, plasticisers, and flavours generally present a lower level of concern – but depending on their concentration may present their own occupational hygiene issues. Both APIs and excipients may consist of a mixture of uncommon hydrocarbons, which are readily detectable by ION Science’s range of VOC gas detectors with patented PID technology.

Patented PID technology is incorporated within our fixed instruments, portable/handheld devices, and wearable detectors for reliable personal protection.

Quality Control

Few industries require as stringent a quality control regime as pharmaceutical manufacturing or are required to meet as many external quality assessments. The industry presents a range of hazards and routinely operates with bio-active substances and potentially hazardous materials, and its products must adhere to strictly controlled international standards.

In practice, most of the world’s pharmaceutical manufacturers adopt the standards and practices required of the world’s largest market for medicines and medical products, the USA. This means adherence to the US Food and Drug Administration (US FDA) protocols, regardless of the actual location of the manufacturing site or the markets being sold into.

In terms of quality control, the specific FDA requirements are known as CGMP, the Current Good Manufacturing Practice regulations. The specific requirements are quite detailed and the FDA puts the onus on the manufacturer to follow best practice and to maintain detailed records of operations. Significant among these is the 21CFR regulations concerning digital signatures and record keeping.

Quality control operations will include continuous monitoring of the atmosphere in production and storage facilities, to detect and quantify the levels of volatile organic compounds (VOCs). A fixed atmospheric monitor such as Falco or TVOC will provide verifiable records and can be integrated into a process control system. Both instruments measure total volatile organic compounds and is highly resistant to atmospheric humidity and contamination.

Fixed monitors placed at strategic locations should be augmented by handheld portable instruments such as those in the Tiger family, enabling spot measurements of volatile organics to be made quickly and easily.

Personal protective equipment issued to workers may include wearable VOC detectors in the Cub range, to verify that individual workers’ exposure remains within limits.