Are Sterile Bioprocess Containers A Source Of Particulate Contamination? (Part 3)

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PharmaTainer 125 mL BottleClick to enlarge.
PharmaTainer 125 mL Bottle
Click to enlarge.

USP 788 Certified Containers Reduce Risk Of Contamination 

Minimize the risk of contaminating your products and possibly compromising patient health. We suggest using sterile ready-to-use containers that meet the USP 788, JP and EP criteria with respect to acceptable particulate levels. Foremost among choices for rigid containers is the PharmaTainer™ product line from Cellon, (www.cellon.lu). 

Execution of the PharmaTainer concept was new from bottom to top to be best-in-class. Cellon built a new, modern facility, exclusively to make single use products for use by biotech manufacturing. All containers are produced on state-of-the-art stretch blow molding (ISBM) machines, supplied with 0.1µ filtered blow air. Molding is in an ISO Class 5 (class 100) environment and capped containers are packaged in an ISO Class 7 (class 10,000) cleanroom.

The environment is cleaned and re-validated weekly and when a machine intervention, such as a mold change, occurs.

PharmaTainer products are validated to meet the USP 788 standard. The USP 788 claim is maintained through a compliance program of frequent cleaning, maintenance and continuous monitoring.

PharmaTainer bottles and carboys are available in polycarbonate and polyethylene terephthalate (PET) in sizes from 125 mL to 20 liters. They can also be customized with tubing assemblies for process sampling and other applications.

Read more about PharmaTainer products at  PharmaTainer Single Use carboys-bottles and PharmaTainer™ Validation Information.

 

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