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REF · 006-PHAR01 / Pharma · Cosmetics

Compressed air for the pharmaceutical industry

Pharmaceutical air without compromise.

The pharmaceutical and cosmetics industry demands compressed air quality without any compromise. Any direct or indirect contact with active ingredients, primary packaging or sterile production areas requires air that is completely free of oil, water and particles - in compliance with ISO 8573-1 class 0 and GMP Guide Annex 1.

Technical challenges

What needs to be solved.

  • 01Guarantee total absence of oil contamination across the entire compressed air chain, from compressor to point of use, under FDA and GMP audit.
  • 02Maintain a low dew point (−40 °C or −70 °C) to prevent any condensation that could compromise sterility or active ingredient stability.
  • 03Document complete traceability (IQ/OQ/PQ qualification, maintenance records, periodic validation) to pass regulatory inspections.
CEZIUM technologies

Our technical answer.

Three families cover most pharmaceutical installations, from the laboratory to the packaging line.

Oil-free scroll

Oil-free scroll

2.2 to 45 kW

Oil-free by design, quiet, compact: the format for laboratories and small production lines, up to 5 m³/min.

13 catalogue models
Oil-free rotary tooth

Non-contacting rotors and TÜV-certified Class 0, for production flows between 2.3 and 8.6 m³/min.

14 catalogue models
Heatless adsorption dryer

Heatless adsorption dryer

0.5 to 83 m³/min

The -40 °C dew point required wherever sterility or active-ingredient stability is at stake.

31 catalogue models
Standards & certifications

Applicable standards.

ISO 8573-1 Cl. 0FDATÜV Classe 0CE

Compliances are verified case by case according to the selected model and audit scope. Complete documentation provided with each machine.

Air quality

The classes usually required

The classes below are the ones we meet most often in pharmaceutical plants. They carry no regulatory weight: your own specification, and it alone, sets the contractual target.

ISO 8573-1 classes commonly met at each point of use, for guidance.
Point of useParticlesWater (dew point)Oil
Air in direct contact with the product or primary packagingClasse 1-40 °C (classe 2)Classe 0
Process air with no product contactClasse 2-40 °C (classe 2)Classe 1
Service air and pneumatic tools in technical areasClasse 2+3 °C (classe 4)Classe 1
House rule

Our order of preference for Class 0

When a specification says Class 0, CEZIUM quotes an oil-free machine, as the trade understands it: scroll compressor up to 5 m³/min, rotary tooth compressor from 2.3 to 8.6 m³/min, dry screw or centrifugal beyond that. We also point out the alternative few suppliers mention: a lubricated screw followed by a treatment chain delivers oil-free air for a markedly lower purchase price, without carrying the Class 0 label.

In this trade, Class 0 means an oil-free machine. That is the convention, and it is what a specification expects when it writes Class 0, so that is what we quote. Technically, ISO 8573-1 classifies air at the point of use rather than the compressor, so a lubricated screw followed by multi-stage filtration and an adsorption dryer delivers oil-free air measured on acceptance. That is a genuine alternative, cheaper to buy and far better at heat recovery, but it does not give you a Class 0 certified machine. Both are worth knowing; your own documents decide.

CEZIUM order of preference among oil-free technologies for reaching Class 0 of ISO 8573-1, with the actual ranges from the catalogue.
RankTechnologyCatalogue flowPowerClass 0Recoverable heatPurchase cost
01Scroll compressor0.3 to 4.96 m³/min2.2 to 45 kWOil-free machineLowModerate
02Rotary tooth compressor2.3 to 8.6 m³/min15 to 55 kWOil-free machineLowHigh
03Dry screw compressor6.8 to 43 m³/min45 to 250 kWOil-free machineLimitedVery high
04Centrifugal compressor48 to 3,000 m³/min198 to 12,055 kWOil-free machineHighVery high
05Lubricated screw + treatment chain0.95 to 44 m³/min5.5 to 250 kWTreated air, no labelHighLow

Flow rates and power ratings taken from the CEZIUM catalogue, oil-free technologies and variable-speed lubricated screw. Purchase cost is given in relative ranks, at comparable flow.

  1. 01

    Scroll compressor

    Up to 5 m³/min

    The first choice below 5 m³/min: oil-free by design, quiet, compact. The right format for a laboratory, a dental practice or a small production line.

    See the 13 catalogue models
  2. 02

    Rotary tooth compressor

    2.3 to 8.6 m³/min

    Above the scroll range and up to 8.6 m³/min. The rotors never touch: no friction inside the chamber, minimal wear, TÜV-certified Class 0. Beyond that flow, several units run in parallel.

    See the 14 catalogue models
  3. 03

    Dry screw compressor

    7.8 to 46 m³/min

    The answer at high flow when the specification says Class 0. We also state its downside: it costs a great deal to buy and lends itself poorly to heat recovery. If your documents ask for oil-free air rather than a certified machine, the previous step is worth quoting alongside.

    See the 20 catalogue models
  4. 04

    Centrifugal compressor

    From 48 m³/min

    Reserved for the continuous base load of very large sites, where no screw compressor can carry the flow in a single machine.

    See the 11 catalogue models
  5. 05

    Lubricated screw + treatment chain

    Alternative, above 8.6 m³/min

    The alternative, when your specification asks for oil-free air rather than a certified machine: multi-stage filtration and an adsorption dryer behind a lubricated screw, with acceptance measurement at the point of use. Markedly lower purchase price, and compression heat is recovered from the oil circuit, which a dry machine does poorly. Rule it out if your documents say Class 0.

    See the 33 catalogue models
FAQ

The questions we are asked

Does Class 0 require an oil-free compressor in pharma?
Yes, as the trade uses the term: Class 0 means an oil-free machine, and that is what we quote when your specification says so, all the more since a pharmaceutical audit often covers the equipment as much as the result. The nuance is worth knowing: ISO 8573-1 classifies air at the point of use rather than the machine, so a lubricated screw followed by multi-stage filtration and an adsorption dryer delivers oil-free air, proven on acceptance. It costs less to buy, but it is not a Class 0 certified machine. So the first question to settle is a documentary one: what exactly do your documents ask for?
Which dew point should a sterile production area use?
An adsorption dryer at -40 °C covers the vast majority of cases: it rules out condensation anywhere in the network, including cold branches. A -70 °C dew point is justified for highly hygroscopic powders or freeze dryers. A refrigerant dryer, which bottoms out around +3 °C, is not suitable for a sterile area.
What exactly does the CEZIUM warranty cover on a pharmaceutical installation?
Three years on the machine, extended to five years for as long as the installation stays supervised by SEENTINEL, and ten years of parts availability, across the whole chain: compressor, dryer and filtration included, not the compressor alone. Wear parts ship within 24 to 48 hours.
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