Oocyte ICSI Zygote Two Cell

Quality Assurance

We aim to provide the highest quality pipettes and microtools through rigorous quality control and quality assurance with certification to ISO 13485, excellent customer service and technical support.
Manufacturing Quality Control

Every pipette is checked and measured repeatedly during manufacture and inspected by an experienced technician before packaging to ensure that they are intact, clean and comply with specifications.
Strict rejection criteria are used during all stages of manufacturing. Pipettes which do not strictly conform to specifications and standards of cleanliness are rejected without compromise.
We discard what other manufacturers sometimes package and sell.
Batch Quality Assurance
Every batch is tested by an independent laboratory using a validated mouse embryo assay (MEA).
To maximise sensitivity: (i) one-cell zygotes are cultured to fully expanded blastocysts (FEB); (ii) a simple culture medium is used to slightly 'stress' the embryos; (iii) protein-free culture medium is used so that toxicity is not masked by protein; (iv) embryos are directly exposed to pipette tips for the entire 96 hour culture period.
Every batch is also tested by an experienced embryologist using a micromanipulator set up to ensure that pipettes are ultraclean, non-sticky and function smoothly and efficiently under routine micromanipulation conditions.
Batch quality certificates can be downloaded from this website.
Other Quality Assurance Procedures
The cleanroom is maintained spotlessly clean, undergoes regular microbiological screening and is certified to ISO 14644 class 7.
Water systems are rigorously maintained, tested regularly for bacteria and endotoxins, and certified annually by the manufacturer.
Packaging materials are thoroughly inspected and tested to ensure cleanliness and sterility.
Packaging and sterilisation processes are fully validated to a Sterilization Assurance Level (SAL) of 10-6 in accordance with ISO 11137.
Guarantee of Quality
If any of our pipettes have manufacturing defects, we will gladly replace them free of charge.

© The Pipette Company 2017 | Modern Slavery Act