You are concerned about biocompatibility and other container quality issues, so we have developed a validation file to assist you. The complete validation file is only available with the completion of a confidentiality agreement (Product literature and Specifications (section 2.X) are available without a CDA)
What’s In The File :
1. General Information
1.1. Product Literature
1.2. ISO 9001-2015 certificate
1.3. Production Overview
2. Specifications (for each container size/material)
2.1. Specification Sheets
2.2. Part Drawings
2.3. Certificate of Compliance (example)
2.4. Batch testing (endotoxin, etc.)
2.5. Packing scheme
3. Resin Information for PET, PC, HDPE
3.1. Resin manufacturer’s data sheet
3.2. Resin manufacturer’s biocompatibility statement  tests specified by the U.S.P. or described by ISO 10993
3.3. Cellon’s method of resin identity confirmation & examples
3.4. Material Safety Data Sheets
3.5. Resin manufacturer’s statements regarding freedom from animal derived components (BSE/TSE)
3.6. Resin manufacturer’s statement with respect to RoHS/ELV/REACH-SVHC/CPSIA/Packaging
4. Biocompatibility Testing of Finished Product
4.1. Biocompatibility testing reports, post sterilization
  4.1.1. USP VI
  4.1.2. In vitro cytotoxicity (MEM)
  4.1.3. Indirect hemolysis
  4.1.4. Leachable Study
  4.1.5. Bioburden and sterility validation
  4.1.6. Endotoxin (example of batch testing)
5. Chemical resistance information
Pharmatainer™ products are currently manufactured in PC and PET in sizes from 125ml to 20 liters. Cellon opened its state-of-the-art production moulding facility in Luxembourg in 2011. The plant is 100% dedicated to production of clean, single- use products for use in the vaccine and bio-processing sector, and operates under an ISO 9001-2015 quality system.
PharmaTainer™ carboys and bottles are manufactured in an ISO class 5 (class 100) environment and sterilised by irradiation to a SAL of 10-6. Certification to the USP 788 is based on liquid particle count analysis on a lot by lot basis.
Designed specifically for the storage and transport of bulk vaccines,biopharmaceuticals, bulk intermediates and other biotech materials,PharmaTainer™ products also provide tamper evident packaging and are first in industry to provide bottle labelling for individual bottle traceability and inventory control.
Speaking for Cellon, Managing director Richard Fry said, “The PharmaTainer™range addressees directly the main quality concerns for single-use storage and transport containers in the industry, i.e. particulate and traceability. By dedicating our facility to production of clean produces, we ensure that all our products aremade to a single, high standard. We reduce risk by manufacturing for a  single purpose and quality standard. So, there is less opportunity for error in our operations than in multipurpose moulding facilities that manufacture products of differing levels of cleanliness using multiple grades of materials.
We welcome customers and prospective customers to visit and/or audit our facility so they may see first-hand the quality systems we have in place”
USP 788 Validation File
Within CELLON we are committed to provide products and services which meet the customers` specified contractual and project requirements. We are totally committed to setting and achieving quality standards that are capable of meeting, in all respects, the specified requirements and reasonable expectations of our customers.
CELLON recognises that in order to provide and maintain a consistently high quality in the work it undertakes, an effective Quality Management System (QMS) is necessary so as to ensure that proper communication, work control and accounting records are generated for all work undertaken.
It is the policy, therefore, of CELLON to control and conduct its businessof manufacturing and supplying products to the Biopharmaceutical industry as well as the Life Science research sector by means of a formalised system of modern quality management. This quality management shall be in accordance with the quality system requirements specified in the appropriate European Harmonised Directives and in accordance with
the principles of ISO 9001:2015 specific requirements.
CELLON has developed, maintains and continually improves a Quality Management System that conforms
to the requirements of ISO 9001:2015 so that we can provide and maintain a consistently high quality in all
work we undertake. Our Quality Management System ensures that proper communication, work control and
accounting records are generated for all work undertaken.
All members of CELLON staff are charged with promoting these aims and are required to familiarize themselves
with the contents of this Quality Manual which defines the Quality Management System that has been established
and adopted as the means for achievingthese declared objectives. Everyone connected with CELLON shall be supported
according to their individual needs for personal development, training and facilities.
The Quality Manager based at the CELLON main office is my appointed management representative responsible for monitoring
and ensuring the correct and effective implementation of the CELLON Quality Management System as whole.
Total Quality Management is applied to every aspect of our activity and quality is the responsibility of everyone,
in every activity, throughout CELLON.

Mission Statement
“To develop value added products through continuous improvement of product design, product validation and the production environment, to meet or exceed customer and regulatory requirements“
PharmaTainer Validation Information
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CELLON S.A - ZAE Robert Steichen - 16, rue Héierchen - L-4940 Bascharage - Grand Duché du Luxembourg - Tel.: +352 26 33 731 - E-mail :
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