Pharmaceutical
Validated, qualified air systems with full documentation.
What we supply for this industry
Oil free scroll compressors
Quiet, small, genuinely oil free. 7.5 to 37 kW at 8 bar g.
- Free air delivery
- 0.8 – 4.0 m³/min
- Working pressure
- 8 bar g
- Motor power
- 8 – 37 kW
Water lubricated oil free compressors
Water seals and cools the rotors instead of oil. Class 0 air, 5.5 to 160 kW.
- Free air delivery
- 0.3 – 27.0 m³/min
- Working pressure
- 7 – 10 bar g
- Motor power
- 6 – 160 kW
Heatless adsorption dryers
Minus 40 °C dew point with no heater. Simple, reliable, uses purge air.
- Free air delivery
- 1.4 – 80.0 m³/min
Nitrogen generators
Make your own nitrogen on site and stop paying for cylinders.
- Weight
- 45 – 1,850 kg
Precision compressed air filters
Particulate, coalescing and activated carbon, to every ISO 8573-1 class.
- Free air delivery
- 1.8 – 80.0 m³/min
Oxygen generation plants
PSA and VPSA oxygen from your own air, 90 to 95 per cent purity.
- Working pressure
- 4 – 5 bar g
Dry screw vacuum pumps
Deep, dry vacuum that tolerates vapour and process carry-over.
- Working pressure
- 0 – 20 bar g
- Motor power
- 4 – 63 kW
- Weight
- 250 – 2,750 kg
Air receivers and storage tanks
0.3 to 10 m³, carbon steel, stainless and vacuum. 8, 10 and 13 bar g.
- Working pressure
- 1 – 13 bar g
- Weight
- 99 – 1,240 kg
Overview
In a regulated pharmaceutical facility, the compressed air system is qualified equipment. Design qualification, installation qualification, operational qualification and performance qualification all apply, and the documentation package is as much of the deliverable as the machinery.
We supply the equipment together with the qualification protocols, calibration certificates, material certificates and change control documentation your quality department will require.
Key benefits
Full qualification package
DQ, IQ, OQ and PQ protocols supplied and executed with the installation.
Continuous monitoring
Dew point, particulate and oil content monitored and alarmed, with data retention.
Redundancy built in
N+1 configuration so a single machine failure never stops a batch.
Change control aware
Any modification documented in a form your QA system can accept.
What the process needs
Oil free air, certified rather than assumed, and a documented path from the compressor to the point of use. In this industry the documentation is part of the product.
Dew point is specified and measured, not indicated. A desiccant dryer with dew point dependent switching and a measured reading is the normal arrangement.
Redundancy is usually a requirement rather than a preference. A batch lost to an air failure costs more than the standby machine did.
- Certified oil free air, ISO 8573-1 Class 0
- Dew point specified and measured
- Documented path to the point of use
- Redundancy designed in
- Sterile filtration at point of use
- Materials and finishes specified
- Validation documentation supplied
- Change control supported
Validation and records
We supply the documentation a validation needs rather than leaving it to be assembled afterwards. Certificates, specifications, calibration records and the service history.
Any work that could affect the air path is recorded and the certification is reissued, because an auditor asks what has happened since the last one.
Change control is respected. We do not alter a setting on a validated system without the paperwork, however small the change looks.
- Validation documentation supplied
- Certification reissued after any works
- Calibration records kept and issued
- Change control respected on every visit
- Engineers briefed on GMP expectations
- Records kept against the serial number
- Copies issued for the quality system
- Support during inspection
How we support a site
Planned work only, scheduled around your production windows, with rental cover where a machine has to come out.
Redundant plant serviced in rotation so there is never a window with no standby available.
And an honest view on specification. Over specifying costs energy every hour, and under specifying costs a batch, so the class is chosen against the actual contact.
- Planned work in your production windows
- Rental cover during any removal
- Redundant plant serviced in rotation
- Specification matched to actual contact
- Priority response on a plan
- Local engineers in every market we serve
- Spares holding agreed for critical items
- Annual review of the whole system
Frequently asked questions
Is the compressed air system qualified equipment?
Yes. In a regulated facility DQ, IQ, OQ and PQ all apply, and the documentation package is as much of the deliverable as the machinery.
What documentation do you provide?
Qualification protocols executed with the installation, calibration certificates, material certificates and change control documentation your quality department can accept.
What monitoring is expected?
Continuous dew point, particulate and oil content with alarms and data retention. Spot checks are not enough for a regulated utility.
Do I need redundancy?
Normally N+1, so a single machine failure never stops a batch. On a product with a long cycle time the cost of an interruption makes this an easy decision.
What air quality class applies?
It depends on the process step, but 1.2.1 or better is common for anything reaching product or primary packaging. We specify against your own user requirement specification.
Does a change to the compressor need change control?
Yes, and we document any modification in a form your QA system can accept, including like-for-like part substitutions where they affect the qualified state.
Oil-free or filtered oil-injected?
Oil-free. In a regulated environment the argument is not about typical performance but about what happens when a filter fails, and with no oil there is nothing to fail.
How do you handle validation of the dryer?
Dew point performance is demonstrated across the operating range and recorded, not assumed from the nameplate. That record goes into the validation file.
Can you support a regulatory inspection?
Yes, we keep the installation and service history and can provide the records and personnel to support an inspection at short notice.
What about cleanroom utilities?
Air quality, pressure stability and low particulate all matter. We size and specify for the cleanroom classification rather than the general plant standard.
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Learn moreNot sure which model you need?
Send us your air demand, working pressure and running hours. Our engineers will size the machine and send a written recommendation, no cost, no obligation.