By Janette Santana, MES and Automation Engineer, ESP; and Baha Korkmaz, Senior VP of North American Operations, ESP
Deploying an MES system or MES individual objects into a production environment, as with any other complex software, has risks associated with it. However, an MES cannot be viewed in the same way as other technology-based system implementations. An MES drastically changes the business process in the same way that operations used to, and as such, has a major impact on the daily business life of end users.
By Bob Chew, ISPE Annual Meeting Chairman
The 2013 ISPE Annual Meeting offers a multitude of opportunities for discovery: insightful presentations, thought-provoking new approaches, case studies, vendor exhibits, regulatory forums, and executive symposia.
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based solely on reliance of vendor certifications, statements, and promises. To diminish such reliance new technologies started to be implemented, such as process analytical technologies (PAT), process controls, automation, etc., only to often once again be overexerted as the solution to all problems: activities that supposedly result in higher product quality due to better process controls.
By Dr. Rüdiger Lomb is Global Director, Quality and Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of nonpharmaceutical, noninvestigator personnel?
By Jack Chopper, Chief Electrical Engineer, Filamatic, LLC
For those who are part of an organization that views the plant floor and enterprise data as necessarily disparate, the unification challenges are both technical and organizational. The technical ones are easy, but the organizational ones — not so much. Most people resist change because it forces them out of their comfort zones. In reality, that's precisely what we need to do! If we expect to drive change, we need to anticipate operating outside of our own comfort zones, and we'll need to ask others to do the same. We must lead by example. I'd like to offer some tips and hints designed to encourage participation by the folks who are capable of connecting the enterprise information and plant floor information systems.
By Andrea Simonetti, Bonfiglioli Engineering SPA
This article provides an overview of the process analytical technology (PAT) methodology application to an automated equipment developed for 100 percent container closure integrity testing (CCIT) of pharmaceutical items.
By Brian Garrett, LEED Green Associate, Product Specialist, Labconco Corporation
The respiratory infectious disease once known as 'consumption' is an infection caused by the bacterial complex tubercle bacilli — TB (tuberculosis forming members of the genus Mycobacterium). Highly contagious, with an infective dose of less than 10 bacilli, more than 20 million cases of Tuberculoses are estimated worldwide. This represents fewer than 10 percent of the total TB carriers. (National Institute of Health, 2009.)
By Jane Metcalfe BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd
This white paper focuses on the challenges facing modern oncology pharmacies concerning the aseptic preparation of cytotoxic drug compounds. It considers the current regulatory as well as the health and safety issues faced by pharmacists, and details some of the measures to tackle these problems such as the use of isolator technology and the application of good manufacturing practice and quality risk management principles.
By Ed Emerson, MOCON, Inc.
In a world full of hungry microorganisms, it is critical that medical devices, designed to heal, do not inadvertently do the opposite by infecting the patient. To prevent infection, a device's packaging, or "sterile barrier system," must maintain sterility over the product's entire shelf life.
By Walt Murray, Director of Quality and Compliance Services, MasterControl Inc
When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.