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PRODUCTS & SERVICES
Product & Materials Division - Test of the Month: Electrosurgical Accessory Testing DDL tests electrosurgical monopolar and bipolar) active accessories and cables. Our testing is used to support 510(k) submissions and to justify CE marking.
Until a few years ago, ANSI/AAMI HF18 was the most widely used standard for electrosurgical accessories in the United States. Its requirements evolved since its first edition in 1986, and it had long been recognized by the U.S. Food and Drug Administration (FDA). The international standard, IEC 60601-2-2, was developed more recently, but its third edition (1998) suffered from a number of shortcomings when compared with HF18, and it was largely ignored, especially in the United States.
Cryopak worked with Carolinas Cord Blood Bank at Duke University to develop a Cord Blood Shipper that would maintain between 4C-30C for at least 36 hours. This kit was designed so that no pre-conditioning was required for the system to function properly. The kits can be stored inside the expectant mother's home and carried to the hospital on their delivery date. The doctor's will then load the system with the required blood collection bag and tubes to be sent back to Carolinas Cord Blood Bank for storage.
Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.
The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective.
Knowing your product's stability requirements, distribution temperature and humidity factors, and your risk tolerances are critical in successful shipments of temperature-sensitive products. Temperature-sensitive pharmaceutical and biologic products have tremendous medicinal and economic value.
Getting them from the manufacturer to the patient requires considerable care throughout the distribution chain.
Patrick Nolan, President of DDL will be representing us at the upcoming Sustainable Packaging Forum & Expo next month in Phoenix, Arizona. DDL will be exhibiting at the show and would like to invite you to register to attend and to stop by our booth to say hi.
Packaging Strategies' 6th Annual Sustainable Packaging Forum will focus on the latest sustainable packaging practices, business strategies and technologies from across the globe that support company growth while meeting today's sustainability challenges.
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
Jean and Anthony will be leading their workshop on Monday, September, 20th, from 2:30-5:30 pm.
TCP Reliable recently completed the acquisition with Isneaufroid, a manufacturer of temperature controlled packaging products located in Maromme, France. These products will be marketed under the Cryopak brand and expands the presence of Cryopak in Europe.
In addition, Isneaufroid offers cold storage services to pre-condition components as well as provide longer term storage and delivery services.
“The acquisition of Isneaufroid brings additional manufacturing capacity of reusable gel pack bottles to the European market and provides Cryopak with a new service capability,” Bill Hingle, Marketing Director said. “This capability provides clients with truly global solutions that are consistent and cost effective”.
DDL, a leader in medical device package, product, and material testing, announces a cooperative agreement with Pennsylvania-based CITECH, which allows DDL to expand its services to the medical device community by adding a new set of industry accepted FDA-recognized tests.
As a result of the agreement with CITECH electrosurgical accessories and electrodes, TENS devices, ECG cables, ECG electrodes and defibrillation electrodes will now be tested at DDL.
DDL and CITECH have tested Luer fittings, needles and syringes, however, with CITECH’s business closing and the agreement with DDL, all CITECH testing of these devices will be routed to DDL which is well established in this specialty area.
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