EU GMP Annex 1
Specify oil and water
All relevant parameters, including oil and water content, should be specified, taking into account the use and type of gas and the design of the gas generation system.
Source: Annex 1 (2022), 6.18.
For sterile medicines, EU GMP Annex 1 (2022) says gases in direct contact with the product should be of appropriate chemical, particulate and microbial quality, with oil and water content specified, and that gases in aseptic processes should pass a sterilising grade filter of 0.22 µm maximum at the point of use. Ultra Controlo distributes and services Gardner Denver oil-free compressors, ISO Class 0, which its catalogue lists for pharmaceuticals, and makes ULTRADRY and ULTRASEC dryers, which its brochure lists for pharma.
EU GMP Annex 1 (2022) and the US FDA aseptic processing guidance (2004) name these uses of compressed air and other gases in sterile manufacturing.
Gases that touch the product or primary container surfaces; oil and water content are among the parameters to specify.
Gases filtered through a sterilising grade filter at the point of use, with the pipework after it sterilised and the gas monitored for microbes.
The FDA guidance notes that compressed air, nitrogen and carbon dioxide are frequently used for purging or overlaying.
Sterile membrane filters for autoclave air lines, lyophiliser vacuum breaks and tanks containing sterilised materials; gas filters should be dry.
Where backflow from vacuum or pressure systems poses a risk to the product, mechanisms to prevent it when the system is shut off.
Sources: European Commission, EU GMP Guidelines, Annex 1 Manufacture of Sterile Medicinal Products, C(2022) 5938 final, 6.18 to 6.20; US FDA, Sterile Drug Products Produced by Aseptic Processing (September 2004), section IV.D.
Neither Annex 1 nor the FDA guidance names a compressor type or an ISO 8573-1 class.
All relevant parameters, including oil and water content, should be specified, taking into account the use and type of gas and the design of the gas generation system.
Source: Annex 1 (2022), 6.18.
A compressed gas should be of appropriate purity, for example free from oil, with microbiological and particle quality after filtration equal to or better than the air of the environment it enters.
Source: FDA aseptic processing guidance (2004), section IV.D.
Lubricant-free air can come from lubricant-free compressors or from lubricant-injected compressors with additional separation and filtration; weigh the risk and cost of product contamination.
Source: Compressed Air Challenge, Fact Sheet #1 (May 2026).
Annex 1 covers sterile medicinal products. Sources: European Commission (2022); US FDA (2004); Compressed Air Challenge (2026).
Annex 1 asks for the parameters to be specified; the ISO 8573 series gives the methods to measure them, and ISO 8573-1:2010 sets the purity classes.
| Parameter | What Annex 1 (2022) says | ISO 8573 test method |
|---|---|---|
| Oil | Specify oil content (6.18) | ISO 8573-2:2018 oil aerosol; ISO 8573-5:2025 oil vapour |
| Water | Specify water content (6.18) | ISO 8573-3:1999 humidity; ISO 8573-9:2004 liquid water |
| Particles | Appropriate particulate quality (6.18) | ISO 8573-4:2019 particle content |
| Microorganisms | Appropriate microbial quality (6.18); periodic monitoring at the point of use (6.19) | ISO 8573-7:2003 viable microbiological contaminants |
Equipment that the Ultra Controlo catalogue and brochure, and the partner makers, tie to the pharmaceutical industry.
Contaminant-free air, ISO Class 0, for pharmaceuticals and food, in the Ultra Controlo catalogue; Gardner Denver says its EnviroAire T/TVS series is certified Class 0 for no oil content by TÜV.
Gardner DenverAdsorption, down to −70 °C, or refrigerated, with a stable +3 °C dew point; the Ultra Controlo brochure lists the pharmaceutical industry for both.
DryersFor aseptic compressed air in the medical, pharmaceutical and food and beverage sectors, per the maker; they can handle sterilisation in place and autoclave sterilisation.
Gardner Denver filtersDry screw vacuum pumps that Elmo Rietschle lists for freeze drying in food and pharmaceutical production. Elmo Rietschle is one of our five partner brands.
Elmo RietschleSources: Ultra Controlo Industrial 2026 catalogue, pp. 11, 12 and 17; Ultra Controlo industrial brochure; Gardner Denver, EnviroAire T/TVS page and filter brochure; Elmo Rietschle, IDS series page.
Ultra Controlo is a Portuguese manufacturer of compressed air, vacuum and technical gas systems, with 40 years of experience. We design, assemble and test our own compressors, dryers and carbon towers in Portugal, and supply and service five partner brands.
ULTRASCREW compressors, ULTRASEC and ULTRADRY dryers and ULTRAK activated carbon towers.
Gardner Denver, Elmo Rietschle, Thomas, Speck Pumpen (Circutec) and Speck Triplex.
Preventive and corrective maintenance, original spare parts and emergency support, by our own team.
Source: Ultra Controlo Industrial 2026 catalogue, pp. 3, 10, 16, 17 and 22.
No. Annex 1 (2022) says gases in direct contact with the product should be of appropriate chemical, particulate and microbial quality, with all relevant parameters, including oil and water content, specified (point 6.18); it does not name an ISO 8573-1 class.
A sterilising grade filter with a nominal pore size of 0.22 µm maximum at the point of use (Annex 1, 6.19), integrity tested where it is used on a batch basis or as a product vessel vent filter.
Annex 1 does not name a compressor type; point 6.18 asks that oil and water content be specified, taking into account the use and type of gas and the design of the gas generation system.
The 2004 FDA aseptic processing guidance says a compressed gas should be of appropriate purity, giving free from oil as an example, with microbiological and particle quality after filtration equal to or better than that of the air in the environment it enters.
The European Commission adopted Annex 1 on 22 August 2022 (C(2022) 5938 final); it came into operation on 25 August 2023, with point 8.123 following on 25 August 2024, and EudraLex Volume 4 lists it as fully applicable since then.
The products, the points where gas meets them, the pressure and the hours per day. We reply with the equipment that fits.
