Here at MySteriLab, we offer the following testing services for medical devices in ISO 17025 accredited lab:
o BIOBURDEN "Sterilization of health care products - Microbiological methods. Part 1: Determination of a population of microorganisms on products" (PN-EN ISO 11737-1),
o STERILITY "Sterilization of health products - Microbiological methods. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process" (PN-EN ISO 11737-2),
o BACTERIA ENDOTOXINS TEST (LAL test) (European Pharmacopoeia - Ph .Eur., Polish Pharmacopoeia – FP, United States Pharmacopeia -USP & National Formulary (NF)),
o Purified water (European Pharmacopoeia – Ph. Eur.),
o Biological indicators “Sterilization of health care products - Biological indicators - Part 1: General requirements” (PN-EN ISO 11138-1 and internal SOP),
o Microbiological monitoring (internal SOP).
With focus on sterile barrier system (SBS) MySteriLab also offers seal integrity testing (in accordance with “Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2”):
o Bubble (ASTM F2096),
o Peal (ASTM F88),
o Dye penetration (ASTM 1929 and EN868),
o Transportation (ASTM D4169 | ISTA Procedures 1, 2, 3),
o Conditioning, accelerated and real time aging (ASTM F1140 and ASTM F2054).
Our microbiological experts are here to help you during testing method settlement and throughout the order process. Now, you can count on our credibility and KNOW-HOW that are confirmed by certifications attests, and validated approvals. You can take advantage of our 20+ year experience in medical device industry as MySteriLab is a part of SteriPack Group.
Company Details
- Employees
- 3
- Founded
- -
- Address
- Ul. Japońska 1, Łęg,poland
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- mysterilab.com
- Keywords
- BIOBURDEN, STERILITY, LAL, Microbiological Testing, Biological indicator, Production water, Validation, Package and material testing, Seal strenght.
- HQ
- Jelcz- Laskowice
Mysterilab. By Steripack Group. Questions
Mysterilab. By Steripack Group.'s website is mysterilab.com
Mysterilab. By Steripack Group.'s LinkedIn profile is https://pl.linkedin.com/company/steripack-laboratory
Mysterilab. By Steripack Group. has
3 employees.
View email and phone details for 3
employees at Mysterilab. By Steripack Group..
Mysterilab. By Steripack Group.'s industry is
Biotechnology Research
Mysterilab. By Steripack Group.'s top competitors are
Kea Ibb,
Kinneir Dufort | Steripack Design & Product Development,
Steripack Group,
Steripack Ireland,
Synektik,
Sandoz Polska,
Polfarmex S.a.,
Novartis Poland,
Yope Sp. Z O.o.,
Tarczyński S.a..
Mysterilab. By Steripack Group.'s categories are Biotechnology Research
Mysterilab. By Steripack Group.'s founding year is 2010
