Need for Particle Engineering Increases
Micronization and other processes are used to obtain optimal particle characteristics for pulmonary and oral solid-dosage delivery.
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Now on PharmTech TV - Cleaning Validation: An interview with Richard J. Forsyth of Forsyth Pharmaceutical Consulting
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Advertisement:
Sartorius has developed a brand-new, scalable range of single-use bags based on an innovative, flexible and robust 400 µm polyethylene film. The Flexsafe product family is used to implement and establish single-use bioprocessing throughout all steps of drug manufacturing—from process development to production. The innovative concept of Flexsafe addresses key industry requirements for reliable and consistent single-use manufacturing of commercial vaccines and drugs.  Learn more
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Diagnosing Facility Mold Infection
Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.
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Tablet Press for Premum Large Batch Production
Fette Compacting America’s FE75 Tablet Press is a double-sided rotary press that can be equipped with up to 115 punch stations to produce more than 1.6 million tablets per hour. Ideal for the premium production of large batches, the FE75’s four compression rollers feature a special control system for direct compression, enabling the machine to operate with two intermediate pressures.  www.fetteamerica.com
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Natoli
Have You Seen the All-New natoli.com?
Natoli’s redesigned website features simpler navigation, online browsing with photos of press parts and accessories, a blog and more. Search our parts catalog by OEM number, manufacturer, or machine. You can also learn more about our two new tablet presses – the RD20 and NP-155.  natoli.com
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Savillex
The Purillex™ range of fluoropolymer bottles from Savillex Corporation is designed specifically for single-use application in the biopharmaceutical downstream process, including storage of API. Manufactured in a clean room for optimal cleanliness, Purillex bottles feature a GL45 closure with a high performance seal. Bottles are available in PFA or FEP, with sizes ranging from 50 mL to 2L. A comprehensive extractables data set is available to support qualification.  www.savillex.com
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Vaisala
Vaisala Mapping Kit: The Quickest Route to Environmental Validation
Reliable data from stable sensors eliminates the need to re-run studies, open deviation investigations, and spend extra time reporting. Simply download the software, place the loggers, and begin your study.
- Compact, rugged loggers are easy to place
- 10-year data logger lifespan
- Fast, simple setup
- 21 CFR Part 11 compliant reporting
- Comprehensive IQ/OQ
 Learn more
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Introducing Tool-Less Valve Maintenance
With a revolutionary mount-and-turn design and no tools or torquing required, the Pure-Flo® EnviZion™ valve from ITT Engineered Valves reduces maintenance costs by over 90 percent. The integrated thermal compensation system eliminates the effects of thermal cycling and provides a reliable seal that does not degrade over time. The result? Significantly lower TCO.  How much will you save?
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Northwest Louisiana Pharmaceuticals Manufacturing Facility Available For Lease
Previous user FDA approved. All equipment is on site and available for tenant use. 29,600 sq. ft. with room to expand on 3-acre site. 4,500 sq. ft. office area, 15,000 sq. ft. manufacturing space, 10, 100 sq. ft warehouse. Excellent central location with immediate access to I-20 and Shreveport Regional Airport.  www.vintagerealty.com
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Jet Pulverizer
New ISO 8 Processing Suite for dry powders
Jet Pulverizer Co. has enhanced their cGMP services by building a new ISO 8 (Class 100,000) classified processing suite for micronizing Pharmaceuticals, Nutraceuticals, Cosmetics, and Foodstuffs. Various processing services are available such as jet milling, hammer milling and screening at cGMP level protocols. The cGMP level includes enhanced cleaning procedures, cleaning verification, and documentation for strict FDA requirements.  FDA registered and inspected facility.
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- Oct. 1–2: Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing Facilities (Bethesda, MD) will cover the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy micro-organisms.
- Oct. 6–8: Management of Aseptic Processing (Bethesda, MD) will provide participants with insight into current inspection trends to keep up with the moving target of cGMP.
- Oct. 16–17: Interphex Life Sciences Innovation Week (San Juan, Puerto Rico) is designed for those specifying, recommending, or purchasing manufacturing, packaging, and operational equipment and technology.
- Oct. 28–30: IVT's Validation Week (Philadelphia, PA) celebrates its 20th anniversary and provides the most up-to-date and comprehensive information on new global regulations, technology advances, and industry case models for developing, implementing, and deploying validation procedures enterprise-wide.
- Nov. 2–6: At the AAPS National Meeting 2014 (San Diego, CA) scientists can network and attend educational programs.
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