Catalent Pharma Solutions is one of the leading providers of advanced dose
form and packaging technologies as well as development, manufacturing, and
packaging services for pharmaceutical, biotechnology, and consumer healthcare
companies in nearly 100 countries. Download the brochure for additional information.
In This Issue
Welcome back to the Pharmaceutical Online newsletter and our spotlight on filling. Check out the right-hand column for a selection of filling products from various vendors in the indsutry. Feel free to browse Pharmaceutical Online's database of filling solutions for additional choices.
Test Area Validation And Flexible Containment System Performance: Testing To The SMEPAC 2005 Guidelines The pharmaceutical industry is insisting that manufacturers provide test data on containment systems they are considering for installation and use. Testing must be performed by a reputable third-party test company with industrial hygiene (IH) experience, and must be conducted in a consistent and defendable manner using standard methodology. This article describes the design and production of a test facility, along with the third-party validation and testing of that facility using the SMEPAC guidelines.
The 505(b)(2) Alternative — An NDA That Saves Time And Money Time is money — a fact well understood by those in the pharmaceutical industry, where developing a new product can take almost a decade and cost hundreds of millions of dollars. Avoidance of costly and time-consuming clinical trials is, therefore, quite desirable for drug companies in the race to bring products to the marketplace before competition.
Supporting The Pharmaceutical Industry With 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical's x-ray diffraction (XRD) systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States' FDA. The paper includes a table that lists the specific sections and requirements of the 21 CFR Part 11 Rule . For each FDA requirement it is explained how this requirement is implemented in PANalytical XRD systems.
A Comparison Of Capacitance And Gravimetric Checkweighers For Capsules Today, manufacturers verify capsule weight using equipment that employs either an electronic field (capacitance) or load cells (gravimetrics). If you're considering adding a capsule checkweigher to your operation, you should understand the principles behind each technology and the appropriate application.
Monitoring Granulation Drying Using Near-Infrared Spectroscopy For more than a decade, NIR spectroscopy and fiber-optic probes have been used for real-time process monitoring. The turbulent flow of powder granules, however, poses a challenge for high-shear granulator moisture analysis monitoring. This paper discusses a novel probe design to reduce the powder-sample density variance such that moisture and solvent levels can be accurately
modeled and predicted.
Product Sheet: Series ABV: Automated Ball Valve
The ABV Series is an economical automated valve package with either an electric or pneumatic actuator. Electric actuated models are weatherproof, NEMA 4, powered by standard 115 VAC supply, and are available in either two-position or proportional control.
Product Brochure: PAGE-Ident Hose Identification System
PAGE-Ident is a hose identification system that offers clear and easily identifiable information that is molded directly to the hose. This is an excellent means of improving your hose inventory, installation, and maintenance programs. PAGE's system aids in efficient hose management by reducing wasted hose life and under utilized assemblies.
White Paper: Sanitary Control Application: Water For Injection Distribution System
Water used for the preparation or processing of pharmaceutical raw materials, drug products, or biopharmaceuticals must meet the requirements for the appropriate grade of pharmaceutical water or needs of the process. The grades for pharmaceutical waters are established in the pharmacopeias as monographs.
Product Sheet: Fill And Finish Manufacturing
DSM Pharmaceuticals Inc. is a leader in the field of fill and finish dosage form manufacturing with world-class capabilities in the areas of aseptic filling, lyophilization, and technology services.
Using its patented Honeycombe Wheel technology, Munters Dehumidification offers five desiccant options and the largest line of industrial dehumidifiers in the world. Individual Cargocaire dehumidifiers and integrated dehumidification systems offer a capacity range of 30 to 100,000 scfm. Download the product brochure for complete information.
Vapor Compression Stills
MECO Vapor Compression (VC) distillers are designed to produce Purified and WFI water in accordance with the U.S. Pharmocopoeia. The distillers meet or exceed cGMP/USP industry standards including sanitary construction features such as double tubesheet heat exchangers, sloped piping and low point drains, minimum deadlegs, and sanitary connections. Download the product sheet for complete information.
A&B Process Systems Water for Injection (WFI) and Purified Water (WPU) systems meet and exceed all established purity standards every day of the week, every week of the year. The WFI and WPU systems are partnered with pretreatment applications and documentation to support validation. Download the white paper for complete information.
Pharmaceutical companies with drugs coming to market in prefillable syringes need a laboratory with specialized testing experience and regulatory knowledge. The testing requirements include chemical analytical testing in addition to functional testing of the syringe system.
This white paper provides an integrated evaluation of plastic packaging forms for standard infusion solutions. The packaging forms bottelpack® bottles (BP-bottles) will be compared with the Non-PVC bags and will be evaluated based on their specific characteristics along with specific production technology.
Interpack Hall 6, Stands B09 - C58
The FXS 5100 filling and closing machine has been specifically designed for the processing of pre-sterilized, nested syringes such as SCF. It has been developed to meet current pharmaceutical industry requirements and address the needs of the end user.
Interpack Hall 16, Stands D13 - E16
STERIFILL F2000 is suitable for liquid solution filling into cylindrical vials and for rubber stopper insertion. The constructive concepts allow the machine to condition vials at high speed (up to 600 pcs/min). The machine is particularly designed for drug processing in aseptic conditions either in traditional class 100 area or in isolation technology.
For more than 20 years, the liquid or semi-solid filling of hard gelatin capsules have been routinely performed by the pharmaceutical industry. Among the various aspects of this technique, the selection of the excipients or fills to be used remains a key step of the development process.