Raw Materials :
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.
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.
Volume : 10ml,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
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.
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.
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 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 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.
Quality system, Product certification, Customer Audits
Cellon business operations business and manufacturing processes are compliant with ISO 9001-2015 . There is a formal change notification policy to provide advance notice in the event of a necessary product change.
Each lot of PharmaTainers bottles is certified to meet our exacting production specifications.
Cellon welcomes the opportunity to show case its manufacturing facility for customers who wish to conduct a plant tour or full production and process audit.
Please contact us for further details and to arrange a date for your visit!