Hazardous locations have or could potentially have high concentrations of flammable gases, vapors, combustible dusts, etc. A small spark can lead to a horrific explosion dangerous to equipment and workers in the area. Equipment located in hazardous areas must be specifically designed to prevent ignition and explosion. DOWNLOAD WHITE PAPER
If you manage a GxP compliant manufacturing facility, or oversee storage and distribution of regulated drugs and devices, this e-book is a convenient and comprehensive reference of definitions, helpful insights, and links to additional resources that will give you fundamental understanding FDA regulations and to achieving Good Manufacturing Practices and FDA compliance.
The Granurex® fluid bed conical rotor system utilizes multiple granulation and coating methods to produce spherical particles with a very uniform shape and size, particles with an exceptionally uniform coating, particles with multiple layers of coatings, particles with very high active content and particles with a high potency with yields of 97 % plus.
This Part II paper describes the disintegration and dissolution aspects of the qualification of a new hypromellose capsule (HPMC Shell 2). This new capsule does not contain any gelling agent, and is manufactured by a thermal gelation process. Rupture time of the carrageenan-containing capsule (HPMC Shell 1) and HPMC Shell 2, as measured by an improved real-time detection method, showed only slight differences that did not manifest in vivo.
The inhalation route is a fast and effective way of delivering medication locally to the lungs and also for the systemic administration of certain agents. Inhalation drug therapy is used extensively to treat respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD).
Remain informed about adjustments to MTSA and learn how the program continues to evolve. This paper provides regulatory updates on MTSA and information about Transportation Worker Identification Credential (TWIC™). Find out about new challenges, including harmonization with CFATS as well as practical tips for compliance.
Selecting a monitoring system for temperature, humidity and other parameters is no easy task. One of the most complicated decisions is selecting the connectivity that will allow the sensors to speak to a central processing unit. In this article we simplify the challenge by describing the most common methods of connecting sensors to a monitoring system. Then we list eight key considerations for selecting a wireless option that will work with your application.
Creating and maintaining upper and lower limits of temperature and relative humidity in the cleanroom is no small feat. Measurement devices play a small role in the overall picture, but problems with measurement devices can cause significant headaches for cleanroom operators. This paper discusses selection and use of appropriate humidity measurement equipment for cleanrooms and is relevant to anyone in the cleanroom community who has struggled with humidity issues.
HEIDENHAIN now offers absolute linear encoders for machine tools with axes up to 28 m (92 ft) in measuring length.
To ensure perfect, high-precision grinding of mineral lenses required by the semiconductor industry, Schüssler-Technik’s torque motors integrate HEIDENHAIN’s angle encoders.
With HEIDENHAIN’s rotary encoders with optimized scanning, electrical drives function reliably and provide dependable measurement data even in harsh conditions.
HEIDENHAIN’s encoders with EnDat digital interface and integral signal evaluation eliminate costs for additional calculations, reduce downtime and increase reliability.
Learn how users leveraged Product Portfolio Management (PPM) technology and best practices to optimize their methodologies and realize benefits like: Improved time to marketHigher product development efficiencyBetter alignment of the product portfolio withcompany strategy Author Jim Brown of research firm Tech-Clarity reveals how PPM plus best practice processes are a great enabler of ROI for product development firms the world over.
International GMP guidelines set standards for independent systems for production, storage, and distribution of medicines. Government agencies are revising their GMPs to use common language and align with these international standards. The new GMP from China’s State Food and Drug Administration (SFDA), effective March 1, 2011, is a recent example. This paper examines the importance of independent systems for monitoring and for control from a regulatory perspective, guides to managing risk to product quality and the consequences of noncompliance.
The new Airchip3000 technology from ROTRONIC reduces humidity and temperature calibration time and cost. Learn how ROTRONIC has eliminated one full step from the calibration process, thus eliminating the cost of the additional calibration cycle.