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We help you safeguard your employees without compromising your product controls

Pharmaceutical production creates two distinct control questions: how you prevent contamination of the product and how you protect employees from potentially harmful pharmaceutical ingredients, sensitising compounds, solvents and biological agents.

The greatest challenge often comes when closed systems are opened for sampling, charging, filter changes, cleaning, line breaking or maintenance, releasing dust, vapour and aerosols. These activities can increase the potential for employee exposure while also requiring careful management of product-contamination controls.

Where Fire Safe International can help

We can help address these changing exposure conditions through task-specific RPE, face fit testing, wearer training and maintenance arrangements that work within your production and contamination controls.

  • 1. Support selecting and fit-testing the right RPE

    The respiratory protection your team need for each task depends on the substance involved, how much may become airborne, how effectively the process contains it and the work being carried out. A health-based exposure limit used under good manufacturing practice (GMP) to control cross-contamination does not establish what employees may inhale or the protection they need. We can work alongside your COSHH assessment and occupational exposure assessment to help review a suitable respirator or breathing-apparatus configuration for each task, then face-fit every tight-fitting mask to the individual wearer. Half masks may be tested qualitatively or quantitatively, while full-face masks require quantitative testing under HSE guidance INDG479.

  • 2. Testing each mask with the full PPE arrangement

    Cleanroom hoods, goggles, spectacles and other head-worn PPE can disturb the seal of a tight-fitting mask. We therefore test your employees while they are wearing the complete arrangement required for the task, allowing any interference to be identified before they enter production.

  • 3. Preparing your equipment and rescue arrangements for non-routine work

    Vessel entry, solvent-system maintenance and work on inert equipment can expose employees to oxygen-deficient, flammable or toxic atmospheres that are not present during normal production. We can help you coordinate the gas detection, breathing apparatus, breathing-air testing and rescue cover required for the permit or shutdown. Calibration, servicing and air-quality records then give your engineering team clear evidence that the equipment is ready before work begins.

Long-term flexibility and value for your organisation

As a long-term partner for your organisation, Fire Safe International can work around your operational patterns and drive value and ROI in several ways.

Avoid last-minute staff changes

We can arrange testing around shifts, gowning access and production campaigns so your employees are cleared before they are assigned to controlled work. Equipment servicing can also be scheduled within your maintenance periods, reducing disruption to planned activity.

Control your testing costs as demand grows

External testing suits smaller or changing wearer populations. If your demand for testing grows or becomes regular, we can train your internal fit testers and supply or hire AccuFIT equipment, helping you move capability in-house when the workload justifies it.

Simplify your RPE purchasing without limiting fit options

Consistent fit-test records can show which masks work best across your wearer population and where alternatives remain necessary. This can reduce unnecessary model variation while retaining suitable choices for different compounds, processes and PPE arrangements.

Who benefits from our expertise? 

Since 1993, we have worked with a variety of pharmaceutical and biomedical customers, including:

Active pharmaceutical ingredient and finished-dose manufacturers
Sterile and non-sterile production facilities 
Contract development and manufacturing organisations 
Pilot plants, laboratories and scale-up facilities
EHS (Environmental, Health & Safety), occupational hygiene, engineering and production teams 

Why work with Fire Safe International? 

Fire Safe International has worked in face-fit testing since 1996 and was involved in the development of the Fit2Fit competence scheme. Our testers and trainers offer both qualitative and quantitative methods, giving your Environmental Health & Safety team one route for disposable masks, reusable half masks and full-face equipment. As the exclusive UK distributor of AccuFIT, we can conduct face fit testing, train your own testers or provide the instrument through purchase or short-term hire – giving you a scalable choice between outsourcing and internal capability.

Book Your Face Fit Test

Can face fit testing be carried out within cleanroom environments?

Usually on site, although testing is completed in a designated area outside the classified cleanroom itself. This is because qualitative testing releases a sweet or bitter aerosol, which may conflict with contamination controls. Quantitative (APC) testing requires naturally occurring aerosols (particles) so this method is also not ideal in cleanroom environments. Uniquely, Fire Safe International is also able to offer CNP type quantitative testing which is suited to clean room environments. Contact us and ask for more information about this if you think it might be useful to you.

How often should our respirators be tested?

Tight-fitting respirators should be face fit tested before first use. HSE guidance does not prescribe a universal retest interval, so organisations should establish a suitable programme based on their risk assessment, local procedures and any changes that could affect fit. An earlier test is required if the make, model or size changes, or if the wearer experiences facial changes such as significant weight loss or gain, facial surgery, dental work or scarring that could affect the seal. Respirators should also be serviced and tested in line with the manufacturer's instructions, and we recommend having them formally inspected, serviced and tested by a trained technician at least annually.

Do you provide nationwide coverage?

Yes. Our teams travel throughout the UK to deliver on-site face fit testing, respirator wearer training, breathing apparatus & respirator servicing, gas detector calibration and breathing-air testing. This allows multi-site pharmaceutical groups to place several facilities under one programme, with consistent test methods, documentation and scheduling across laboratories, production areas and distribution sites.

What next?

To find out more, please call 01743 761000 today to speak with one of our specialists, or arrange a consultation to review your current programme.