SPECIAL REPORT

SERIALIZATION

CALIFORNIA 2015 & BEYOND

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Sterlization

Articles on the processes used to reduce or kill bacteria on or in packaged products, such as gamma irradiation, steam/EtO, etc..

Combination products, with a nutraceutical twist

Packaging, regulatory agencies will be challenged to keep pace with developing combination product therapies....

Pharmaceuticals and biologics | July 20, 2011

Evaluating sterile technologies via a ‘bottom-line’ approach

Using return on investment helps when considering isolators and restricted access barrier systems technologies....

Packaging Line Efficiency | January 11, 2010

Steris System 1 Processor: FDA Notice and Recommendations

FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices....

FDA, regulatory and legal | December 7, 2009

FDA Data Standards Update - SPL Terminology Update

The FDA Data Standards Council’s website was updated Wednesday, November 18, 2009, to include updated terminology:...

FDA, regulatory and legal | November 30, 2009

Sterile stoppers

• a range of sterile stoppers is available for antibiotic, infusion, and lyophilization vials • stoppers are sterilized using gamma radiation • delivered in double-walled PE bags or containers for use in an isolator STELMI...

Ampules, vials, syringes and tubes | April 13, 2009

Beyond cleanrooms: Debating RABS and isolators

Are restricted access barrier systems (RABS) and isolators replacing traditional cleanrooms? All have the same aseptic requirements, but some argue that isolators and RABS increase asepsis. Many companies, especially large pharmaceuticals, are making the switch from cleanrooms to RABS...

Misc. Archive | February 15, 2008

Medical device packaging training track at MD&M West conference

A medical device packaging track chaired by Randall Troutman (shown in photo), CPP, Oliver Medical Products, will take place from 9 a.m. to 4 p.m. Monday, Jan. 28, during the MD&M (Medical Design & Manufacturing) West Conference at the...

Medical devices | January 22, 2008

Sterilizable medical film

• M312 is a biocompatible polyolefin pharmaceutical film that withstands a rigorous 121ºC (252ºF) sterilization process • offers leach resistance and low-temperature flex crack and fracture resistance, is plasticizer and PVC-free, and has a low moisture vapor transmission rate •...

Flexible films, lidding and foils | January 10, 2005

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