Standards

HealthPack to Feature Expanded Standards Update

Speakers at the upcoming HealthPack event March 6-8 in Albuquerque will update attendees on industry-specific AAMI, ISO, ASTM, and ISTA standards.

Perfecseal Facility Certified To Class 7 Cleanroom Standards

 
Perfecseal has certified its Oshkosh, WI sterile medical pouch and bag manufacturing facility to ISO 14644-1 (1999) Class 7 cleanroom standards.

2012 GTIN Sunrise and GTIN Allocation Rules for Healthcare

The Global Trade Item Number is the fundamental product identification key in the GS1 System. Uniqueness at every level of packaging is essential…and soon.

We hear a lot these days about sunrise dates in the global GS1 System of product identification and related supply-chain standards. A sunrise date is a date in the future, agreed to and typically announced years in advance, at which point an industry or market sector is expected to be prepared to implement a specific technology.

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DDL East Expands

DDL, a provider of package and product testing services, is expanding its testing facility in Edison, NJ. The company has recently increased its testing capabilities for thermal performance testing and conditioning for thermal testing.

Chamber space at DDL East now includes:

*1200-cu-ft walk-in chamber, capable of up to 6 pallets, with a temperature of 5 degrees C

*1200 cu-ft walk-in chamber, capable of up to 6 pallets, with a temperature range of 30 to 50 degrees C for development projects

HIBCC Standard for RFID and Medical Devices Approved by ANSI

ANSI has given final approval to the standard Radio Frequency Identification (RFID) HIBC for Product Identification developed by the Health Industry Business Communications Council (HIBCC).

The standard, ANSI/HIBC 4.0, concerns electromagnetic interference (EMI) of RFID with medical devices. HIBCC recommends that 13.56 Mhz High Frequency (HF) be adopted for healthcare item level tagging because its smaller read range is less likely to result in EMI with medical devices.

Rexam Pharma now ISO 15378 Certified

Rexam Pharma (Suresnes, France) has received certification in accordance with ISO 15378:2006 at two European production sites. The new standard combines ISO 9001 and GMP requirements in one complete quality system. First published in August, 2006, ISO 15378 is aimed toward primary pharma packaging manufacturers. Rexam’s sites in Nuremberg, Germany, and La Verpilliere, France, received compliance approval in June.

Toward Global Standards in the Healthcare Supply Chain

Raise the bar on patient safety and efficiency.

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Standard Issue

EPCglobal provides guidance in the growing world of pedigree technologies.

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Regulatory Focus: OMAC and ISA Officially Announce Merger

Two entities will combine to integrate and broaden standards.

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Roundtable: Securing Pharmaceuticals

Security packaging technologies are needed, but so are open standards that involve everyone in the supply chain.

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