A reminder to pharma manufacturers, the Drug Supply Chain Security Act (DSCSA) deadlines are quickly approaching. Have you planned for the implementation of Transaction Documents for your packaged products and how to introduce them into your supply chain? Have you developed a strategy for implementing packaging serialized data and infrastructure?
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International Pharmaceutical Expo (INTERPHEX), sponsored by Parenteral Drug Association (PDA),...
International Pharmaceutical Expo (INTERPHEX) has announced the appointment of Kate McCorriston...
The landscape for today’s supply chain now extends to the horizon and beyond. Components, materials and API’s are now sourced from around the world, and controlling the delivery, cost and quality of these items is more important than ever. Outsourcing is no longer a creative option, it is an expectation for successful companies who need to minimize capital expenses and limit their exposure to risk.
Sterile biopharmaceutical product manufacturing remains a dynamic and challenging segment of our industry. This session will bring regulators and industry together to discuss expectations and explore trends focused on the use of technology, risk based decision making, process capability, and quality systems needed to achieve the objective of manufacturing excellence.
The March issue of Pharmaceutical Processing is our INTERPHEX 2014 show issue and features numerous highlights from show exhibitors. In addition, we also announce the winners in our new Facility Excellence Awards program.
This session will provide an update on the PDA Task Force that is discussing strategies and risk management of Aging Facilities, and discuss some specific examples of unique challenges that manufacturers must deal with these facilities to maintain Good Manufacturing Practices.
With 25 years in operation, Praxis is an FDA cGMP certified contract packaging company specializing in secondary packaging for the consumer product, cosmetic, food & beverage, OTC and Rx pharmaceutical markets as well as bottling of oral solid dosage products.
The Water Interest Group addresses topics in pharmaceutical water quality, analytical and microbiological control, rouging and biofilm concerns, continued water monitoring and compendial issues. The interest group is providing for an on-going forum for the exchange and dissemination of information and ideas for the purpose of education, innovation, and compliance related to purified water science.
As drug development continues to increase complexity, so do the primary packaging solutions that are being employed. Primary containers are no longer to considered as inert components whose sole function is to contain a drug product, but rather as an integral part of a drug delivery system.
IPS-Integrated Project Services a leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities has announced four presentations to be given by the company’s subject matter experts during INTERPHEX 2014 in New York City.
The PCMM (Portable Continuous Miniature & Modular) from GEA Pharma Systems and G-CON (Booth 2421) comprises a system that integrates a small footprint, continuous processing equipment, smart control systems and PODs (portable, self-contained GMP modules) to process API powders and inactive ingredients through to bulk tablets.
The Norwich Pharma Services manufacturing facility in Norwich, New York is as varied in its capabilities as it is its equipment investment strategy. This dedication to growth through equipment and technology investment has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
Custom Processing Services has a strong track record of contract manufacturing in the pharmaceuticals marketplace. And on November 11, 2011 that legacy was strengthened with the opening of a 42,000 square foot facility dedicated to GMP processing, with two unique GMP processing stations. This commitment has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
The Caliber Biotherapeutics manufacturing facility in Bryan, Texas offers an interesting look at the development and integration of Plant Made Pharmaceuticals. This commitment to new and innovative drug development strategies has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
New development technologies, expanded contract manufacturing and service capabilities, as well as innovative equipment investment strategies highlight leading practices from the best in pharmaceutical processing comprise the 2014 Pharmaceutical Processing Facility Excellence Award winners.
Ramiro Fernando Goni Barba, a partner of CHRIS HILLSETH ENTERPRISES and a veteran of the softgel industry, has been chosen by INTERPHEX 2014 to give a presentation titled “Scientific Advancements in Softgel Technology that will Drastically Change Manufacturing”.
The Jan/Feb 2014 issue of Pharmaceutical Processing is our INTERPHEX 2014 Preview issue and features numerous exhibitor highlights and a guide to the educational conference program. In addition, we profile Xcelience, a clinical trial material contract manufacturer based in Tampa, FL.
During INTERPHEX 2014, March 18th -20th, Pharmaceutical Processing will be sponsoring several Innovation Sessions on important industry topics.
The NanoRam handheld Raman spectrometer offers cost-effective rapid identification and verification of APIs, excipients, intermediates, and finished products, allowing users to eliminate quarantine areas as well as maintain sample volume and integrity through non-destructive sampling.
Allegro single-use mixers are part of the company's expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering principles and criteria for robust mixer design to deliver the ultimate in mixing performance.
Saniflo™ Hygienic Series AODD Pumps meet the strict needs of pharmaceutical manufacturers because they have been specifically designed to satisfy the regulatory guidelines established by the U.S. Food & Drug Administration (FDA) for sanitary process applications and are available with a full validation package.
BioPure single-use tubing connector systems simplify production operations, lower costs of GMP Pharma manufacturing and reduce process validation time. Peristaltic pumps contain fluid to be pumped ensuring isolation from any source contamination.
This single-use line of four-piston diaphragm pumps is designed for utilization in biologic-handling applications within pharmaceutical and biotech operations. The Quattroflow product line consists of five pump sizes—QF150, QF1200, QF4400, QF5050 and QF20K—with capacities between 1 and 20,000 L/hr (5,283 gph).
The 266-Fold Outsert allows for an expanded number of panels which, in turn, yields a significant increase in copy space for necessary product information and instructions. As a result, the need for a “twinsert,” or piggybacked outsert, often is eliminated.
The PharmaFlex 750 Deduster is equipped with an insight metal detector from Lock Inspection Systems. The combination tablet deduster/metal detector showcases the company’s comprehensive AIO Tablet Deduster and Tester System. Short for “All In One,” the system builds upon the PharmaFlex family of dedusters by offering turnkey peripheral devices as integrated solutions.
The Intelli-Pac Manual Case Aggregation System for serialized cartons or bottles features an ergonomic design and stainless steel construction.
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