By Joseph Pickett, President, ExpertBriefings.com
When many companies respond to an FDA 483 they tend to address each specific violation in their response letter. Although they are addressing the individual complaints, they never actually get down to solving the underlying problems.
Developing a response letter that addresses the inspectional observations, as well as the underlying problems, has become more challenging. The agency is now putting more pressure on drug manufacturers to answer within 15 workdays after an inspection closes out. The clock is ticking, and your time is running out!
By Robert Rosen, Filamatic
Solve foaming problems with our bottom-up filling technique. This technique can be used on both semi-automatic and automatic equipment. Bottom-up filling allows the nozzles of each pump to be inserted into the container and rise just above the liquid as the liquid rises. Bottom-up filling ensures a smooth fill and eliminates the foaming of your product.
By Scott Anderson, Kathy Lawrence, Dennis McCreary, and Melissa Wilcox
By using the RevealX™ detection technology of the Reveleris® system, which independently triggers fraction collection from multiple detectors including UV and ELSD, this work will demonstrate that these bottlenecks can be reduced or eliminated without reducing the recovery of compounds of interest.
By BW (Ben) Marguglio, President, BW Marguglio, LLC
Any enterprise that is engaged in activities that have the potential for public and employee harm should be encouraged, if not required, to develop and implement an integrated risk management, safety management, quality management, and environmental management system for the prevention of events with intolerable effects.
By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick
Bulk transportation of temperature-sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. This imperative has prompted pharmaceutical companies to look at more efficient and economical means of temperature-controlled distribution. Passive packaging systems are one of the proven and repeatable methods for international bulk shipments of temperature-sensitive products.
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
With conventional centralized automation of process valves in production units for food, drinks, and pharmaceutical products, it is often difficult to meet the necessary stringent hygiene and safety standards. Intelligent process valves with integrated automation functions offer an interesting alternative in this field, and can help reduce planning, installation, and maintenance costs.
By Brian Garrett, LEED Green Associate, Product Specialist, Labconco Corporation
ASHRAE Standard 55-2004 determines the temperature, humidity, and airflow at which the average worker is comfortable; and though people in many industries have the luxury of dressing for the seasons, laboratory workers are usually burdened with an extra layer or two of protective garb. So, room atmosphere considerations also need to take into account that many laboratories have their own requirements as to temperature, humidity, and airflow (ventilation). All of this adds up to a laboratory having very strict conditions regarding the facility's internal air quality.
Q&A with Mike Odom, Thermo Fisher Scientific
In this Q&A, Mike Odom, general manager, product inspection business unit, Thermo Fisher Scientific, gives his insights into the challenges of product inspection, the advantages of inspection technology, the FDA recommendations for inspection, and how product inspection will evolve in the future.