Pharmaceutical dusts and APIs monitoring in an industrial workplace

Specialist monitoring

Pharmaceutical Air Monitoring

Pharmaceutical air monitoring assesses exposure to active pharmaceutical ingredients (APIs) and process dusts, verifying containment performance against occupational exposure bands and limits.

Method

OEB / SMEPAC

Sampling

Personal & static

WEL (EH40)

ALARP / COSHH

Turnaround

5–10 working days

01

What is pharmaceutical air monitoring?

Pharmaceutical dusts and APIs monitoring measures the airborne concentration of potent active pharmaceutical ingredients, excipient dusts and process aerosols that workers may breathe in during normal operations. It quantifies real personal exposure so employers can judge whether existing controls are adequate.

IndustrialAirMonitoring.uk provides independent pharmaceutical air monitoring across pharmaceutical manufacture, fine chemicals, contract manufacturing, research and development sites throughout the UK. Our occupational hygienists deliver defensible exposure data that demonstrates compliance with the Control of Substances Hazardous to Health Regulations 2002 (COSHH) and the workplace exposure limits set out in HSE guidance note EH40.

02

Why pharmaceutical air monitoring matters

Under COSHH Regulation 10, employers must monitor exposure to hazardous substances where it is needed to protect health, where a workplace exposure limit could be exceeded, or where control measures need to be verified. Pharmaceutical dusts and APIs monitoring provides the objective evidence that satisfies this duty.

Uncontrolled exposure to pharmaceutical dusts and APIs is linked to potent pharmacological effects, sensitisation and respiratory harm at very low concentrations. Beyond the legal duty, robust monitoring protects your workforce, reduces the risk of enforcement action and civil claims, and gives insurers and clients confidence that exposure is being actively managed.

03

How we carry out pharmaceutical air monitoring

We measure exposure using high-sensitivity personal and surrogate sampling with specialist low-level laboratory analysis, following the recognised OEB / SMEPAC methodology. Personal samplers are worn in the breathing zone for a representative full shift to derive an 8-hour time-weighted average, while static (background) samples help map contaminant sources across the workplace.

Samples are analysed by an accredited laboratory and the results compared with the relevant occupational exposure limit. Where short-term peaks are a concern we add 15-minute short-term exposure limit (STEL) sampling, so both the chronic and acute risk picture is captured.

04

Standards, limits and reporting

Pharmaceutical dusts and APIs is controlled to as low as is reasonably practicable, with sampling benchmarked against published occupational and in-house standards. We assess compliance using the BS EN 689 statistical decision framework, which accounts for exposure variability rather than relying on a single result.

Your report sets out the measured concentrations, the compliance position, the adequacy of existing controls such as local exhaust ventilation, and a recommended re-monitoring interval. It is written to be understood by managers and to satisfy HSE inspectors, auditors and insurers.

05

Our pharmaceutical air monitoring process

Our pharmaceutical air monitoring programmes follow a structured, four-stage workflow so the results stand up to scrutiny. Request monitoring or book a site assessment to begin.

  1. 1Scoping & site survey. We review your processes, COSHH assessments and previous pharmaceutical air monitoring data, then plan a representative sampling strategy using BS EN 689 similar exposure groups.
  2. 2On-site sampling. Qualified occupational hygienists carry out calibrated breathing-zone and static measurements across a representative shift, with full chain-of-custody documentation.
  3. 3Accredited analysis. Samples are analysed using the relevant MDHS / ISO laboratory method and the results are compared against the applicable workplace exposure limit.
  4. 4Reporting & recommendations. You receive a clear exposure report with compliance status, control recommendations and a re-monitoring interval — defensible evidence for HSE, insurers and auditors.
06

Frequently asked questions

What are occupational exposure bands (OEBs)?

OEBs group compounds by potency to set very low containment targets for APIs; monitoring confirms whether containment achieves the required band.

Can you measure very low API concentrations?

Yes — we use high-sensitivity sampling and specialist low-level analysis suited to potent compounds.

Do you assess containment equipment?

We can carry out containment performance testing (e.g. SMEPAC-style) and routine exposure monitoring.

Next step

Need pharmaceutical air monitoring for your site?

Request monitoring