IsoCell Pro Advanced Therapy Isolator
ISOCell PRO Cell Therapy Isolator, can be the answer to your needs by providing a streamlined workflow environment reducing the set up and running costs of cell therapy products preparation!
- Simplicity of the ISO 5 location and easy gowning for most applications since isolator systems dedicated to cell production may be located in a non-classified room with restricted access;
- Security with validated sterility of the working area and cross-protection of product/operator/environment.
- Traceability for all the steps of the sterile handling process.
- The initial sterility is provided by a dedicated H2O2 vapor (HPV) program to bio-decontaminate the work area and the material access area
- The sterility is maintained with the positive pressure of HEPA-filtered air. The outlet HEPA prevents against any return of non-sterile air.
The IsoSkin Medium
Through the manipulation of donor tissues of skin, the R&D laboratory for Regenerative Medicine works in the directions to develop all the reagents, media, growth factors and protocols needed to produce artificial skin for a clinical purpose.
IsoSkin Medium Kit
for artificial skin is a reagent of the ISOCell line to support researchers in clinical translation.
IsoSkin Medium Kit
culture medium is formulated to produce artificial skin in vitro.
It is an optimized medium contains components to efficiently growth multilayers epidermal keratinocyes in only three weeks avoiding the use of colera toxin.
Primo®3PACK: triple packaging plasticware
As defined by the European Regulation Advanced therapy medicinal products (ATMPs), are gene therapy medicinal products, somatic cell therapy medicinal products, tissue-engineered products (TEP).
They constitute a major class of innovative therapeutics that are being investigated as treatments for several diseases and organs repair.
Good Manufacturing Practice (GMP) compliant procedures are a prerequisite for cell production in clinical application and clean rooms are ideal zones for cell therapies production.
Production equipment are regulated in : EU Guidelines to Good Manufacturing Practice, Chapter 3 Premise and Equipment, section 3.39 and Annex 1 section 81.
: triple packaging plasticware according with EU Guide lines have these features:
- Sterilization - Products labelled sterile meet a minimum requirement of 10-6 SAL (Sterility Assurance Level).
- Non-Pyrogenic - Products labelled non-pyrogenic have been validated per FDA guidelines on LAL (Limulus Amebocyte Lysate) testing for medical devices and company guidelines. The acceptance level for product is less than 0.5 EU/mL.
- DNase & RNase Free - This product has been tested and is free of any detectable DNase / RNase contamination
- Tested as NON citotoxic
The Euroclone products are manufactured under the ISO 9001:2008 and ISO 13485:2012 standards Quality System Compliance
Triple Packed Product Handling
The Primo® 3PACK plasticware have three individual tear to open bags , all the tears are positioned at the TOP of the packages
Inner bag is labeled with relevant product information, LOT and EXP
IsoCell Sanitized Packaged Reagents
The most common potential forms of contamination in cell cultures are bacteria (including Mycoplasma), yeasts and fungi, and these can be readily assessed on a routine basis.
To avoid sources of contamination in cell factory or in our IsoCell Pro Isolator, we offer a
CLEAN SOLUTION TO SUPPORT YOUR CLINICAL TRANSLATION.
These media, buffers and supplements are offered in single sanitized packaging.
The packaging process is made in a controlled environment with quality management system comply with ISO 9001: 2008 and UNI EN ISO 13485: 2012.