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4501 Ficha Técnica

This document provides product information for a 50mL pipette including: - Component materials of polystyrene and polyester that meet USP and cytotoxicity requirements - Product dimensions such as overall length, volumetric accuracy, and tolerances - The pipette has been sterilized to meet a SAL of 10-3 and tested to be non-pyrogenic and DNase/RNase free - Quality control testing includes visual inspection, packaging inspection, and integrity tests that the pipette passed

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27 views1 page

4501 Ficha Técnica

This document provides product information for a 50mL pipette including: - Component materials of polystyrene and polyester that meet USP and cytotoxicity requirements - Product dimensions such as overall length, volumetric accuracy, and tolerances - The pipette has been sterilized to meet a SAL of 10-3 and tested to be non-pyrogenic and DNase/RNase free - Quality control testing includes visual inspection, packaging inspection, and integrity tests that the pipette passed

Uploaded by

Rene
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Catalog Number: 4501

Product Description: PIPETTE, 50ML, PW, PS, S, IND, 25BAG

Component Materials:
Pipette - Polystyrene meets USP, Class VI requirements for plastic containers and closures.
Polystyrene also meets USP Cytotoxicity Test <87>.
Mouthpiece Plug - Polyester, meets USP Cytotoxicity Test <87>.
Ink - Purple/ black, meets USP Cytotoxicity Test <87>.

Product Dimensions:
Overall Length - 14.52 in.+/- .050 in. Tip ID - .125 in.
Max Working Volume - 60 mL Mouthpiece OD - .310 in.
Volumetric Accuracy - +/- 2% stated full volume Pipette OD - .705 in.
Tolerances of ID & OD - +/- .015 in.

Sterility - Product has been sterilized and dosimetrically released per the requirements of ANSI/AAMI/ISO 11137,
-3
"Sterilization of health care products- Radiation". Products meet a minimum Sterility Assurance Level (SAL) of 10 .

Non-Pyrogenic - Tested and met the criteria established in the current version of ANSI/AAMI ST 72, "Bacterial
Endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing". The acceptance level for product
is ≤ 0.10 EU/ml or ≤ 4 EU/device.

BSE/TSE – This product is deemed animal free by virtue of not containing materials of animal origin and/or complies with
the latest revision of EMA/410/01 section 6.4.

DNase/RNase Free - Tested by nuclease assay method and found to be free of detectable DNase/RNase contamination.
-7 -9
The assay detection limit is 10 Kunitz units/uL for DNase and 10 Kunitz units/uL for RNase.

Volumetric Accuracy - Serological pipets are accurate to +/- 2% at full volume in compliance with ASTM E934,
"Standard Specification for Serological Pipet, Disposable Plastic" and ISO 12771, "Plastics laboratory ware - Disposable
serological pipettes".

Quality Control Testing - Representative production samples are collected and inspected in accordance with current
applicable product specifications. Inspection records are reviewed and approved by qualified personnel for product
release. Key inspections and inline tests are listed below:
Visual Inspection - Pass
Packaging Inspection – Pass
Integrity – Pass

Lot Number Designation:


8 Digit Lot Number: First 3 digits – Julian date, start of manufacturing; Next 2 digits – Year of manufacture; Last 3 digits
– Batch identification.

Rev 18

Plant of Responsibility: 2 Alfred Rd. Kennebunk, ME 04043 Tel: 1-800-492-1110

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