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Critical environment gloves

Biogel® Tech range is a portfolio of sterile, PPE-certified gloves specifically designed for use in critical environments such as pharmaceutical or biotech manufacturing facilities, research laboratories or hospital pharmacy compounding units. Suitable for use in aseptic and Class 100 (ISO 5)/EU GMP Grade A environments.

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Overcoming challenges in critical environments

It is essential to use high quality equipment in a critical environment to protect the process, the product and the operator.

Biogel® Tech range

The Biogel^® Tech range is a portfolio of sterile, PPE certified gloves specifically designed for use in critical environments such as pharmaceutical or biotech manufacturing facilities, research laboratories or hospital pharmacy compounding units.

Suitable for use in aseptic and Class 100 (ISO 5)/EU GMP Grade A environments.
Exceeds industry standards for force at break, tensile strength and elongation¹.
Low liquid particle count².
Over and undergloves can be worn together to form a Biogel^® breach indication system with best-in-class perforation detection^3,⁴.

Feel the difference with Biogel® Tech gloves

Biogel^® Tech are hand-specific gloves that have been ergonomically tested to reduce hand fatigue and are designed to be comfortable, even when you are double gloving^5-⁷. With high dexterity and tactile sensitivity, your hands can do their job, while the Indication System lets you focus without fear of missing a micro hole, tear or puncture⁸.

Packaging designed for critical environments

The double-bagged, heat sealed packaging complies with critical environment hygiene protocols and ensures simplicity of use as the layers of packaging can be removed one at a time.

High quality plastic inner wrap to keep particle count to a minimum
The wrapping stays open when unfolded to ensure aseptic donning

Biogel® Tech range of gloves are made to protect the process, the product and the operator

Biogel gloves are made to such a high standard, we have a whole facility dedicated to quality control. You could say we’re obsessive: every single batch of Biogel gloves undergoes rigorous quality checks, extensive performance assessments and multiple visual inspections along the development stages¹. Even more, every single glove (100%) is air inflation tested for holes typically not detected in a visual inspection⁹.

AQL of 0.4 (freedom from holes), determined post packaging¹.
Every glove (100%) is air-inflation tested for holes typically not detected in a visual inspection⁹.
Low endotoxin level (<20 EU/pair)¹.
Highly controlled sterilisation to a minimum of 25kGy.
Produced in a controlled environment with strict hygiene standards throughout the facility. All of our facilities conform to ISO 13485 and ISO 14001¹.

References
Summary of Technical Documents. Mölnlycke Health Care. Data on file.

Liquid particle count test. Eurofins, 2021.

Wigmore SJ & Rainey JB. Use of coloured undergloves to detect puncture. BJS 1994: 81:1480. https://doi.org/10.1002/bjs.1800811026

MHC Report, Glove puncture detection systems, GMCS-2017-098. Data on file.

Collins J. A Clinical Investigation to Evaluate the Biogel PI Micro Surgical Glove. Mölnlycke Health Care, 2014. Data on file.

Gottrup F, Müller K, Bergmark S, Nørregaard S. Powder-free, non-sterile gloves assessed in a wound healing centre. Eur J Surg. 2001 Aug;167(8):625-7.

Carter S, Choong S, Marino A, Sellu D. Can surgical gloves be made thinner without increasing their liability to puncture? Ann R Coll Surg Engl. 1996 May;78(3 (Pt 1)):186-7.

Summary of Indication Performance of Biogel Gloves Indicator Systems versus Competitors' Double Gloving Combinations. October 2020. Data on file.

SOP LR2200. Automatic Glove Inspection by QMAX. Mölnlycke Health Care. Data on file.

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Critical environment gloves

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Overcoming challenges in critical environments

Biogel® Tech range

Feel the difference with Biogel® Tech gloves

Packaging designed for critical environments

Biogel® Tech range of gloves are made to protect the process, the product and the operator

See how Biogel gloves are made

Critical environment certificates

References

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