PharmaTainer Vials in PET or PC for stability studies
 
10mL PharmaTainer Stability Vials are available to enable customers to evaluate and monitor drug substance storage. Small stability containers are beneficial in early stages of the drug development cycle when materials are only available in small quantities. Later in the product life cycle using a small stability container minimizes the consumption valuable drug substance in testing. PharmaTainerTM stability vials are manufactured from the same materials* used in larger PharmaTainer bioprocess storage containers. The 29 mm HDPE closures feature the same double-seal system found through-out the PharmaTainerTM product range.
 
Vials are available in both Polycarbonate and PET. Brim capacity of the vial is 12 ml. The vials come packed 49 in a high density (30g/l) foam rack which has a tight closed cell structure, ensuring low particle emission and excellent shock absorbing capabilities. Each rack of 49 vials is provided in a poly vacuum pack and then over-packed in a heat-sealed sleeve. Each carton contains 5 double bagged racks of vials for a total count of 245 vials per carton.
 
Cap torque chucks are also available to enable closures to be applied with a known and consistent torque force.
PharmaTainer Polycarbonate Bottles & Carboys :
 
Polycarbonate has a wide temperature range of use. PharmaTainers PC bottles & carboys are ideal for frozen storage.
 
Volume : 10ml , 125 ml, 500 ml, 1, 2, 5, 10 & 20 liters
 
Temperature range of use : -130°C to +120°C
 
Clear and easy to read graduations with an accurancy of +/- 2 %
 
Certified sterile and endotoxins tested
PharmaTainer PET Bottles & Carboys :
 
PET provide excellent gas barrier properties. PharmaTainer PET bottles and carboys are ideal for long storage of materials like culture media
 
Volume : 10 ml,  125 ml, 500 ml, 1, 2, 5, 10 & 20 liters
 
Temperature range of use : -40°C to +60°C
 
Clear and easy to read graduations with an accurancy of +/- 2 %
 
Certified sterile and endotoxins tested
Manufacturing production records.
 
Comprehensive production records are collated and maintained for each PharmaTainer  production lot, including raw material certificates,  FTIR scan test results, machine and operator details for all production stages, QC records, sterility and endotoxin test certification are all recorded. Samples of all raw material lots and final product lots are retained  and maintained for future reference if required.
 
Sterility
 
Sterility certification for the PharmaTainer product family is based on a VDmax25 sterilisation study performed according to ISO11137-2:2007. VDmax25 sterilisation of health care products- radiation-part 2, to demonstrates that a 25kGy irradiation dose achieves a sterility assurance level (SAL) of 10-6. Ongoing sterility assurance is maintained by bioburden assessments on every product batch and quarterly VDmax25 dose audit studies.
 
Endotoxin
 
Endotoxin testing is carried out as part of the product release criteria for each manufacturing lot.  The test is carried out by an independent laboratory by means of using a validated assay method using  a 5% rince volume and a detection limit of 0.001EU/ml that complies with current USP and EP Bacterial endotoxin test (BET) methodologies.
Packaging :
 
PharmaTainer products are packed in an ISO14644-1 class 7 clean room to minimise the impact of particulate from packaging in your controlled environments. PharmaTainer products are shipped in cartons with 3 layers of internal packaging to aid delivery into your clean room manufacturing  areas. The innermost packing layer is vacuum sealed to provide assurance of an intact sterility barrier. The second bag is heat sealed and the third bag (carton liner) is folded and tape closed. Clear labelling of all levels of packaging simplifies your inventory control and enhance traceability throughout your processes.
Traçability :
 
Each container  is printed with a unique serial number, batch number, expiration date and machine readable data matrix to provide unrivalled traceability through the production process  at Cellon and during use at your facility.
Features :
 
Volume : 10 ml, 125 ml, 500 ml, 1, 2, 5, 10 & 20 liters
 
High clarity for exceptionnal visibility of contents
 
Easy to read printed black graduations, accurate to +/- 2%
 
Indented, ribbed handgrip on the 500 ml, 1 & 2 liters
 
Unlinded, double seal closure system
Manufacturing :
 
PharmaTainer   bottles are manufactured in our state -of-the-art  facility which dedicated to the production of sterile single use  products for use in Pharma  industries.
Production is by an injection blow molding process  that produces bottles with a precision, flash-free, and burr- free neck, eliminating the primary cause of seal failure. 
An extensive ongoing  quality control program ensures uniformity of production and conformity to our exacting manufacturing specifications.
Molding and capping are performed in a class 100 environment to minimizing  the possibility of particulate, bio-burden or endotoxin inside the container.
Raw Materials :
 
PharmaTainer products are manufactured from 100% virgin ADCF resins that are approved by our suppliers for medical applications and selected by Cellon for their performance, clarity and biocompatibility.
 
Bottles and Carboys are manufactured from Polyethylene terephthalate (PET) and Polycarbonate (PC). Closures are manufactured from natural (non coloured) High density Polyethylene. (HDPE)
 
All raw materials are approved for medical use by our suppliers and are supported by drug master files held by the FDA.
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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 : sales@cellon.lu
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