Single-use assemblies

Puresu single-use tube assemblies

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Overview

puresu single-use tube assemblies

Custom single-use assemblies designed for your bioprocess

puresu® is a combination of different components that can be customised to your requirements. Through a broad range of tubing and single-use components combined across an open architecture design, we work with you to create a sterile and dependable fluid path customised to your bioprocessing requirements.

Each of our single-use assemblies are manufactured in-house and are lot traceable throughout our process. To ensure our single-use technology comes ready to use, and meets the requirements set by cGMP guidelines, lot traceability of each component can be made available as part of our detailed documentation.

Assembly and packaging are carried out in our ISO 14644-1 Class 7 Cleanroom manufacturing suite. Sterile tube assemblies are available with a 10-6 SAL and a two year sterility shelf life, validated in compliance with ANSI/AAMI/ISO 11137 VDmax 25 methodology.

Features and benefits

Sterile tube assemblies are available with a 10-6 SAL (sterility assurance level)
Safe, flexible and quick turnaround backed with a robust supply chain.
Complete product traceability.
Large component library to choose from.
Documented quality systems compliant with ISO 9001.

Technical summary

Certification	ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI
Sterility	Gamma irradiated (minimum 25 kGy), Non-irradiated, Sterile (10-6 SAL)

Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.

Specifications

Technical specifications

	puresu
Certification	ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI
Sterility	Gamma irradiated (minimum 25 kGy), Non-irradiated, Sterile (10-6 SAL)

Validation

About the puresu single-use tubing assemblies validation guides

puresu®是一个一次性组装,可用在variety of custom configurations for use in bioprocessing. They comprise of single-use components including Watson-Marlow tubing, ReNu SU cartridges, BioPure connectors and gaskets, as well as a number of industry recognised third party supplies.

Validation summary guide details manufacturing process.
BioPure employ ISO 9001 quality management systems within their Horndean facility, UK.
Assemblies are manufactured and packed in ISO 14644-1 Class 7 cleanrooms.

puresu® assemblies can be provided double or triple bagged depending on customer requirements. These assemblies can also be provided in three categories

Non-irradiated.
Gamma irradiated to a minimum of 25 kGy with a certificate stating irradiation dose range.
Gamma irradiated with a sterile claim of 10-6 SAL per ANSI/AAMI/ISO 11137 (VDmax method).

Each assembly has a unique lot number which enables each component to be fully traced to its constituent materials.

Validation summary guide

The summary guide summarises the validation/qualification testing that has been carried out on puresu single-use tubing assemblies.

View puresu summary guide [File size] - 405.6kb

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Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

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Literature

Brochures

Bioprocessing (EN).pdf
PDF - 3.5mb
puresu brochure (EN).pdf
PDF - 1.2mb

Datasheet

Sterility

We work with you to deliver a final design that is specific and reliable to your bioprocessing needs. To align with your requirements, puresu® single-use assembly packaging configurations may include non-irradiated, gamma irradiated (minimum 25 kGy) or gamma irradiated with a 10-6 SAL claim.

Sterile puresu®

Ideal for critical fluid path bioprocesses and customers unable to terminally sterilise. Supplied gamma irradiated with a sterile assurance level claim (10-6 SAL). Suitable for customers who require contamination risk mitigation.

Gamma Irradiated puresu®

Suitable for customers who manage microbial control through bioburden reduction.

Non-Irradiated puresu®

Suitable for prototype evaluation and the application of alternative sterilisation methods.

Configurations

We employ an open architecture approach to enable flexibility of your assembly designs. puresu® assemblies are available with the following:

A range of fluid path components including Watson-Marlow Tubing products (ReNu SU cartridges, Pumpsil®, PureWeld® XL, BioPure tubing, BioPure tubing fittings, sanitary hose barbs, Bio-Clamps, valves and adaptors)
Product options include: non-gamma irradiated, gamma irradiated (minimum 25 kGy) or gamma irradiated with a sterile claim (10-6 SAL).
Documented quality systems compliant with ISO 9001

Comparison

	Pumpsil®	Bioprene®	PureWeld®	GORE® STA-PURE® PCS	GORE® STA-PURE® PFL	BioPure Braided Hose
Bore sizes available	0.5 mm - 25.4 mm	0.5 mm - 25.4 mm	0.5 mm - 25.4 mm	1.6 mm - 25.4 mm	1.6 mm - 15.9 mm	3.2 mm - 25.4 mm
Wall thickness available	1.6 mm - 4.8 mm	1.6 mm - 4.8 mm	1.6 mm - 4.8 mm	1.6 mm - 4.8 mm	1.6 mm - 3.2 mm
Operating temperature	-20 °C to 80 °C	5 °C to 80 °C	-20 °C to 80 °C	-20 °C to 80 °C	-20 °C to 80 °C	-65 °C to 254 °C
USP Class VI	✔	✔	✔	✔	✔	✔
European Pharmacopoeia 3.1.9	✔	✔		✔		✔
ISO 10993	✔	✔	✔	✔		✔
Up to 10,000 hours pumping life		✔		✔	✔	✔
High pressure capability (2-7 bar)		✔		✔	✔	✔
Low gas permeability		✔	✔		✔
Wide chemical resistance		✔	✔		✔
LaserTraceability™	✔
Lot traceable from raw material to finished product	✔	✔	✔	✔	✔	✔
Gamma stable	✔		✔			✔
Autoclavable	✔	✔		✔	✔	✔
Animal Derived Component Free (ADCF)	✔		✔	✔	✔	✔

	Bio Y™	BioBarb™	FlatBioEndCap™	BioEndCap™	BioClamp®	Q-Clamp™	BioValve™	Gaskets
Sizes available	¹/₄” - 1”	¹/₈” –⁵/₈”¹/₈” – 1”	¹/₂” – 2¹/₂”	¹/₂” – 1¹/₂”	¹/₂” – 8”	¹/₂”-1”	¹/₈” – 1¹/₄” OD Tubing	¹/₂”-6”
Pressure rating	4 bar	4 bar	4 bar	4 bar	6-10 bar	7 bar	10 bar	6-10 bar*
Can be gamma or autoclave sterilised	✔	✔	✔	✔	✔	✔	✔	✔
USP Class VI	✔	✔	✔	✔	✔	✔	✔	✔
European Pharmacopoeia 3.1.9	✔	✔	✔	✔				✔
Animal derived component free (ADCF)	✔	✔	✔	✔	✔	✔	✔	✔
Polypropylene	✔	✔	✔	✔
Glass reinforced nylon					✔	✔	✔
Platinum-Cured Silicone								✔
Tamper evident sizes					¹/₂” – 4”	Both Variants	Both Variants