Pharma and aseptic filling
Sterile garment kits, hooded coveralls, sterile gloves and masks for GMP A/B.
Cleanroom garments. Clearly chosen.
Cleanroom garments for sterile and controlled areas
Every person sheds hundreds of thousands of particles every minute. Cleanroom garments contain them and protect product and process in pharma, medical devices, semiconductor manufacturing and laboratories. ProSafe cleanroom offers a complete system: coveralls, frocks, hoods, overboots, sleeve covers, gloves, masks, goggles and socks, plus tacky mats, wipes and swabs.
Available now are the articles from the DS SafetyWear B2B shop, for example the ProSafe 2 coverall and the CleanMax frocks. New in preparation is a sterile line of 42 articles for GMP A/B: garment kits, cleanroom gloves and masks, whose target specifications you can already review here.
Status of the new line: 42 articles in preparation. The figures for these articles are target specifications for series production, not product commitments. With your enquiry we register you for pre-series samples and the delivery date.
Our product groups
Cleanroom coveralls
9 articlesHooded and mandarin-collar coveralls in microporous laminate and tri-laminate, sterile and non-sterile.View articles
Frocks, jackets, trousers and aprons
6 articlesTwo-piece suits, frocks and aprons in microporous film laminate, available now.View articles
Sterile garment kits
4 articlesCoverall, hood and overboots sterile in one pack for one gowning cycle.View articles
Cleanroom hoods
6 articlesSeparate hoods with shoulder yoke, with and without integrated mask, sterile and non-sterile.View articles
Overboots and overshoes
6 articlesKnee-height overboots, ESD overboots with conductive ribbon and overshoes, sterile and non-sterile.View articles
Sleeve covers
5 articlesExtra-long sleeve covers with thumb loops and sleeve protectors, sterile and non-sterile.View articles
Cleanroom gloves
13 articlesLatex, nitrile and neoprene gloves in 300, 400 and 600 mm, sterile and non-sterile, for double gloving and cytotoxic drugs.View articles
Cleanroom masks
6 articlesThree-layer masks with earloops, ties or visor, sterile, irradiated or non-sterile.View articles
Cleanroom goggles
2 articlesAutoclavable goggles with anti-fog panoramic lens, closed or vented.View articles
Cleanroom socks
1 articlesLow-linting disposable socks, mid-calf, for gowning before the cleanroom.View articles
Tacky mats
32 articlesProSafe tacky mats in eight formats, white or blue, packs of 4 or 20, available now.View articles
Cleanroom wipes
12 articlesPolyester, nonwoven and pre-wetted cleanroom wipes plus absorbent mats, available now.View articles
Cleanroom swabs
15 articlesFoam and polyester swabs in various head shapes and shaft lengths for ISO 4 to 8, available now.View articlesWhy ProSafe cleanroom
Procurement for the cleanroom needs substantiated information. That is why every article shows what purchasing, quality assurance and production need for their decision.
Data sheet for every article
Material, sizes, pack size and standards framework at a glance; evidence on request.
Sterile and non-sterile
One system of coverall, hood, overboot, glove and mask for GMP A/B to D and ISO 4 to 8.
Honest information
For the new line we state target specifications and label them; commitments come only with test reports.
Ordering in the B2B shop
Available articles are ordered directly in the DS SafetyWear B2B shop.
Advice from Cologne
Reply within 24 hours, samples free of charge for business customers.
Which equipment suits your area?
The finder shows which product groups belong to your area. Whether an individual article meets the requirement is decided by the data sheet and your contamination control strategy.
Knowledge: understanding cleanroom garments
Guides on cleanroom classes, the garment system, sterility, particle shedding, gloves, masks and standards, plus a glossary.
Cleanroom classes
Particle limits per class, how ISO and GMP classes relate and what that means for garments.
Read the guideGarment system
Coverall, hood, overboots, gloves, mask and goggles only work together. How to gown correctly.
Read the guideSterility
Validated sterility, sterility assurance level, gamma or X-ray and the difference from aseptically folded.
Read the guideUse in practice
Medical devices and laboratories
Frocks, hoods and overshoes for controlled areas, goggles and latex-free gloves.
Semiconductors and electronics
ESD overboots with conductive ribbon, antistatic gloves, wipes and swabs for ISO 4 to 8.
Data sheets and evidence
For available articles the product data sheet is binding. For the new line we show target specifications and label them as such.
Product data sheet
Article, version, unit and technical details.
Per article as web pageTarget specification new line
Material, dimensions, standards framework and design targets of the 42 articles.
In preparationTest reports and conformity
Particle shedding, sterilisation validation, EU conformity.
With release of the seriesEnquire about suitable cleanroom articles
Tell us cleanroom class, task and quantity. We reply with a product suggestion and data sheets.
Order in the DS SafetyWear B2B shop. Prices in the shop are shown without VAT; shipping costs may apply. You manage your account and VAT ID in the shop.
Choosing cleanroom garments: advice
Cleanroom garments form a system. Coverall, hood, overboots, gloves and mask must match each other and the class of the room. The ISO class to ISO 14644-1 describes the particle count of the air; the GMP grade to EU Annex 1 describes the requirements for sterile manufacturing. Which garments are prescribed is set by your contamination control strategy.
To choose, first clarify area and task, then the delivery condition (sterile or non-sterile) and finally details such as hood or mandarin collar, glove length and mask fastening. We are happy to advise on classes, standards or target values.
What is the difference between sterile and aseptically folded?
Sterile means validated sterilisation, usually by irradiation, with a sterility assurance level of 10⁻⁶. Aseptically folded only describes the folding that allows donning without touching the outside; it says nothing about sterility.
Which garments does GMP Grade A/B need?
Usually sterile, individually packed garments: hooded coverall or hood plus mandarin collar, overboots, sterile gloves, mask and often goggles. The exact scope is set by your operation.
What does Helmke Category I mean?
The Helmke drum test to IEST-RP-CC003 measures how many particles a garment sheds. Category I is the best level with fewer than 1,200 particles ≥ 0.3 µm per minute.
When will the new line be available?
The 42 articles are in preparation. With your enquiry we register you for pre-series samples and the delivery date; test reports follow with the release of the series.
Where do I find cleanroom wipes and swabs?
Tacky mats, wipes and swabs are in our overviews with shop link; detailed product pages are on prosafe-esd.eu.
The brand family of DS SafetyWear Arbeitsschutzprodukte GmbH
Each brand leads in its category. ProSafe® cleanroom is a product line of the ProSafe® brand.
