Newsletter | April 1, 2008

4.1.08 -- Testing To The SMEPAC 2005 Guidelines

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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.

Our featured article provides an overview of the SMEPAC 2005 guidelines and how to accomplish validation of a test facility using these guidelines. Also included, in this isssue, is an article on the 505(b)(2) NDA and how it can help you avoid costly and time-consuming clinical trials. Other topics focused on in our editorial section include: using x-ray diffraction for 21 CFR Part 11 regulations, a comparison of capacitance and gravimetric checkweighers, and monitoring granulation drying with near-infrared spectroscopy. Be sure to read our Top News Stories section for the latest happenings in the pharmaceutical industry. Included is an announcement by Sartorius and NewAge Industries, who are partnering up to offer value-added solutions to the biopharmaceutical industry, and how the R&D spending by U.S. biopharmaceutical companies reached a record in 2007.
Featured Editorial
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 [2]. 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.

Top News Stories
R&D Spending By U.S. Biopharmaceutical Companies Reaches Record $58.8 Billion In 2007
Sartorius Stedim Biotech And NewAge Industries AdvantaPure Team To Offer The Biopharmaceutical Industry Value-Added Solutions
Tongjitang Chinese Medicines Announces Definitive Purchase Agreement To Acquire Qinghai Pulante Pharmaceutical Company
Bio-Imaging Acquires Phoenix Data Systems, A Leading Provider Of Clinical Data Services
HistoRx And Lilly Extend, Expand AQUA Analysis Partnership
China Biopharma Reaches Agreement With A Regional Pharma To Launch New Pharmaceutical Products
Taro Receives FDA Approval For Ondansetron Hydrochloride Injection USP, 2 mg/mL ANDA
Eriez Introduces A New Generation Of X-Ray Inspection Systems
APP Pharmaceuticals Launches Cefepime Hydrochloride For Injection
PAGE-Flex SBF Smooth Bore Assemblies Increase Flexibility
Mettler-Toledo Thornton Delivers Calibration Tools Verifying USP Compliance Of Conductivity Measurements
Honeywell Expands Aclar Production For Pharmaceutical Industry
Copley Scientific Inhaler Testing Tools Help QbD Implementation Through Faster Data Acquisition
TAKE Solutions' Life Sciences Division Announces Global Expansion Of Its Submissions Assurance Program
Circulation Publishes Data Showing KYNAPID (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation To Sinus Rhythm
Featured Downloads
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.

Editor's Choice Products

Viton®
Viton® fluoroelastomer is the most specified fluoroelastomer, well known for its excellent (400°F/200°C) heat resistance. Viton® offers excellent resistance to aggressive fuels and chemicals and has worldwide ISO 9000 registration. Download the product brochure for complete information.

Blue Mountain Regulatory Asset Manager For Validation
At the core of Blue Mountain Regulatory Asset Manager, are its integral features to manage the validated state of assets. The software brings together the information and personnel required to maintain and oversee all assets and processes within a single platform. Download the product brochure for complete information.


Climate Control
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.

PureFeed DP-4 Disc Feeder
Specifically designed and developed with pharmaceutical companies for pharmaceutical processes, the PureFeed DP-4 Disc Feeder is a highly innovative gravimetric feeder that can accurately meter dry pharmaceutical, nutraceutical, and even cosmetics powders at feed rates as low as 20 grams/hour. Download the product brochure for complete information.


VirTis Benchmark Lyophilizers
The Benchmark Series Freeze Dryers are engineered to process pilot to production scale batches of pharmaceutical and biotech products. Benchmark series freeze dryers have numerous options that allow the customer to configure the freeze dryer to fit any pharmaceutical application. Download the product brochure for complete information.

Dust Collectors for Tablet Coating
The Gold Series (GS) dust collector can be used in a variety of pharmaceutical dust collection applications such as tablet presses, tablet coating, fluid bed dryers, spray dryers, and general room ventilation. The GS is perfect for high efficiency filtration in pharmaceutical manufacturing. Download the product brochure for complete information.


Clean In Place System (CIP)
IPEC provides custom designed CIP process skid systems for leading manufacturers in the food, dairy, pharmaceutical process manufacturing, biotech, beverage, and cosmetic industries. A wide variety of systems are available upon request. All will be specified and built to optimize chemical, water, and energy usage. Download the product brochure for complete information.

Portable Flame Sterilizer: FLAMEBOY
FLAMEBOY is a handy, mobile flame sterilizer with piezo-electric ignition for safe sterilization. The size of the smooth flame is adjustable. If used as portable, DVGW safety certified version it is at hand wherever you need it: production plant, fermenter, laboratory, or outdoor. Download the product sheet for complete information.


Laboratory Mixers: LabRAM and LabRAM Vacuum
The LabRAM mixer is an indispensable bench top mixer for the laboratory. It utilizes ResonantAcoustic® Mixing technology to achieve thorough and consistent mixing. The LabRAM mixer can mix a broad combination of gases, liquids, solids, powders, and pellets. Download the product sheet 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.


X-Series High Shear Mixer
The X-Series High Shear Mixer being offered by Charles Ross and Son Company includes a unique rotor-stator generator that creates high shear rates at tip speeds up to 17,000 feet per minute. The X-Series mixers in are offered in several standard industrial and sanitary designs up to 250 hp. Request additional information from Charles Ross and Son Company.

Citrajet: Low Foaming Liquid Acid Cleaner
Low foaming, phosphate-free, concentrated, liquid cleaner and metal brightener for high performance removal of metal oxides, scale, salts and inorganic residues in labware washers, parts washers, power-spray systems and manual and ultrasonic cleaning. Corrosion inhibited and free rinsing leaving no interfering residues. Download the product sheet for complete information.


WFI Systems
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.

2D Micro-HPLC System For Proteome Analysis
This high-performance 2D capillary-to-microflow HPLC system co-developed by Shimadzu and the NIH (National Institutes of Health) performs separation of complex peptide mixtures with a level of sensitivity and resolution that complements present 2D gel electrophoresis. Download the product sheet for complete information.


Kramer Tablet Dedusters E5000WIP: The Wash-Down Deduster
The E5000 WIP (wash-in-place) or CIP (clean-in-place) is a self-contained Kramer model deduster specifically used for dedusting and conveying high potent products to reduce operator exposure levels (OEL). Download the product sheet for complete information.

Getinge (GEVC) Ventilator And Cascading Terminal Sterilizers (Autoclaves)
Getinge's ventilator sterilizers (GEVC's) are designed primarily for sterilizing products whose container or package must be dry at the end of the cooling phase or whose products can be distorted or damaged in standard steam processes (i.e., plastics). Download the product brochure for complete information.


Batch Fluid Bed Granulators And Dryers
Batch Fluid Bed Granulators and Dryers are typically used for process applications requiring rigorous final product uniformity, particle size, moisture content, and morphology. Because of their ability to achieve consistent batch-to-batch repeatability, Glatt's products are universally accepted within the pharmaceutical industry. Download the product brochure for complete information.

XS2 Checkweigher
Security and flexibility, the XS2 delivers proven performance for up to 600-gram packages. The XS2 delivers the performance, flexibility, and innovation that is the hallmark of all Hi-Speed products. Download the product sheet for complete information.

Spotlight On Filling

Product Sheet: Prefillable Syringe Systems
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.

White Paper: Packaging Form Comparison: bottelpack® Bottles Versus Non-PVC Bags
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.

Product Brochure: Bosch Syringe Filling — FXS 5100
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.

Product Brochure: IMA In Aseptic Liquid And Powder Processing
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.

White Paper: Liquid Filling In Hard Gelatin Capsules — Preliminary Steps
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.

Product Sheet: T 200 Double: Tube Filling Equipment
The T 200 Double tube filler can handle up to 10,000 tubes/hour for metal tubes and up to 8,000 tubes/hour for polythene, polyfoil, or laminate tubes.
Industry Events
cGMP For Quality Assurance And Quality Control Of Pharmaceuticals, Biopharmaceuticals, And Biologics
April 7 — 9
Dublin, Ireland

505(b)(2): A View From The Experts
April 10
San Francisco, CA

The Pharmaceutical Business From Drug Discovery Through Product Launch
April 10
Washington Crossing, PA

HunterLab Color Seminar
April 10 — 11
Reston, VA

PDA 2008 Annual Meeting
April 14 — 18
Colorado Springs, CO

International Powder & Bulk Solids (Part of PTXi)
Donald E. Stephens Convention Center
May 6 — 8
Rosemont (Chicago), IL

Single-Use Manufacturing In Pharma And Bioprocessing
May 14 — 15
Bridgewater, NJ
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