Watson-Marlow Bioprene tubing products equivalency statement

WATSON-MARLOW TUBING
Watson-Marlow Bioprene
tubing products
equivalency statement
Background
Watson-Marlow Bioprene tubing is designed for peristaltic pump
applications in the biopharmaceutical industry. It has two key features
making it ideal for use in the biopharmaceutical industry:
• Bioprene tubing is designed to perform optimally with Watson-Marlow
pumps, providing excellent accuracy and reliability
• The raw material and tubing are fully qualified to strict biocompatibility
standards. This high specification is achieved through exacting
manufacturing controls from raw material selection through to product
testing
Change of raw material
Our supplier has rationalised the family of polymer products to which the
Bioprene raw material belongs. This has resulted in the withdrawal of the
raw material currently used in Bioprene manufacture (henceforth referred
to as RTS0XX). We have secured sufficient stock of RTS0XX to ensure
continuity of supply until July 2014. We have also worked with our supplier
to identify and qualify an alternative to RTS0XX for use in Bioprene
manufacture.
The purpose of this equivalency statement is to demonstrate equivalency
of Bioprene tubing made with the new raw material (henceforth referred
to as RTF0YY) and Bioprene tubing manufactured with RTS0XX. Customers
can be assured that they will continue to receive identical peristaltic
performance and biocompatibility.
Equivalence
1. Raw material
Bioprene products are extruded from RTF0YY, belonging to the same
thermoplastic product family as RTS0XX. This comes from the same
supplier and meets the requirements of USP Class VI testing. As RTF0YY
and RTS0XX are virtually identical, the customer can expect equivalent
chemical compatibility from Bioprene tubing made with RTF0YY.
Test RTS0XX RTF0YY
USP Class VI In vivo tests Pass Pass
USP Cytotoxicity Pass Pass
USP Physicochemical Pass Pass
Watson-Marlow Bioprene tubing products equivalency statement 1

2. Manufacture
Bioprene tubing continues to be extruded in an ISO 14644-1 Class 7
(Class J/10,000) cleanroom according to cGMP principles, operating within an
ISO9001:2008 quality system. There are no changes to the manufacturing
conditions.
Bioprene made from RTF0YY is manufactured in the same sizes as RTS0XX
and to the same tolerances in dimensions.
3. Biocompatibility
Bioprene tubing extruded from RTF0YY has passed the same biocompatibility
tests as tubing extruded from RTS0XX (refer to: Bioprene validation guide,
Issue 2, 2007).
Test
Tubing from RTS0XX
P/N range 903.XXXX.XXX
Tubing from RTF0YY
P/N range 933.XXXX.XXX
USP Class VI In
vivo tests
Pass
Pass
USP Cytotoxicity Pass Pass
ISO 10993-4
Haemolysis
ISO 10993-12 Kligman
sensitization
FDA 21CFR177:2600
(aqueous)
USP
Physicochemical
USP Elastomeric
enclosures
PCBs - EPA 8080 (now
8082)
USP Endotoxin
LAL assay
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
NB: Testing on standard Bioprene grade only. For other hardness grades please refer
to the Bioprene validation guide, Issue 3, 2013
4. TSE/BSE statement
The RTS0XX raw material was supplied with a declaration according to EMA 410/01
rev.1 (2003) covering the use of material with animal origin. RTF0YY comes with
the latest revision of the same declaration – EMA 410/01 rev.3 (2011).
5. Peristaltic performance
Testing has been carried out on representative sizes of tubing and elements,
made from both materials, including different hardness grades where
appropriate. Two indicators of peristaltic performance were employed:
• Life in hours to the point of failure
• Percentage drop in flow rate on a daily basis until failure
Watson-Marlow Bioprene tubing products equivalency statement 2

All the performance results show that Bioprene tubing made from RTF0YY
material performs equivalently to tubing made from RTS0XX, when tested
under comparable conditions.
6. Physical properties
The following table shows that the physical properties of both raw materials
are equivalent, allowing for errors in measurement.
Parameter RTS0XX RTF0YY
Hardness (Shore A, 5s) 63 - 69 62 - 68
Specific gravity 0.95 – 0.99 0.95 – 0.99
Ultimate tensile strength
(psi)
800 - 99999 798 - 99999
Elongation at break (%) ≥340 ≥340
Stress at 100%
elongation (psi)
280 - 470 276 - 435
NB: The above table shows details for standard Bioprene grade. For equivalent data for
other Bioprene hardness grades please refer to the Bioprene validation guide, Issue 3, 2013
7. Packaging and labelling
There is no change to the packaging of Bioprene tubing. Bags and boxes are
labelled with the description, part code, lot number, expiry date and barcode
of this information.
In order to control the change of material, new part numbers have been
created for Bioprene made with the RTF0YY material
• 903.XXXX.XXX codes change to 933.XXXX.XXX
• 088.0250.XXX codes change to 088.T250.XXX
Summary
From selection of raw material through to biocompatibility qualification and
peristaltic performance testing, Bioprene 933 tubing made with the RTF0YY
material is demonstrably equivalent to Bioprene 903 tubing extruded from
RTS0XX. The customer can have full confidence in continuing to use Bioprene
in their validated biopharmaceutical applications.
In addition, with the introduction of the RTF0YY material the tubing has been
registered as a Drug Master File with the FDA (Federal Drug Authority). Every
batch of raw material (RTF0YY) and a sample of tubing extruded from it is
USP and USP tested, giving assurance that both will continue to
meet USP Class VI requirements.
Further details on the biocompatibility qualification can be obtained in the
Bioprene validation pack, available by registering at: www.wmpg.com/
validate. Further advice and information to aid the validation process can
also be found at the same site.
Watson-Marlow Bioprene tubing products equivalency statement 3