Equipment Processing Report by PharmTech logo
March 2012  
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Production Lines

Modular Factory Concept Gains Traction
Modular factory concepts, which take flexible manufacturing to the next level, are beginning to take hold in the biopharmaceutical industry.

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In The Mixer

Container Design Meets Powder Handling Needs for Single-Use Mixing Systems
Powder container design affects discharge rate, cleanability, and powder flow. Flow problems, such as ratholing, arching, and erratic flow, can be eliminated with appropriate container geometry.

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>>Coming Soon: For an article on manufacturing equipment and purchasing trends, see the April issue of Pharmaceutical Technology.

Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.



Troubleshooting Editor's Picks

Reducing Waste in Tablet Coating

In our tablet coating process, we are losing up to 15% of our coating solution in each processing run. What can we do to prevent this problem in order to reduce waste and increase our cost efficiency?


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Editor's Pick product

Editor's Pick product

The ARTMiS Automated RealTime Milling System within Powder Systems's containment unit provides an advanced processing solution for jet milling of powders.
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Editor's Pick product

EMD Millipore introduces a larger, 1000-L mixing container for single-use powder mixing and delivery.
Read More at PharmTech.com


Showcase (Sponsored)
Bosch

Bosch Packaging Technology will be demonstrating the latest in syringe filling technology in their booth at Interphex. The fully equipped line includes a Bag Opener, Tub Opener, and Filling system for nested syringes. The line also has the Combi filling system capable of running a variety of dosing options on the same machine. Click to preview the system.
 
W.S.Tyler

Custom Metallic Filtration Products for Prototypes and Small Runs

W. S. Tyler specializes in design, service, consultation and fabrication of custom metallic filters for prototyping and small production needs. These products are constructed in stainless steel, Hastelloy, and other metallic filter mesh and/or metal sintered laminates. They allow migration-free filtration from 1 to 200 micron. The filter grade woven wire cloth is available in several twill designs to meet specific filtration application requirements.
Pharmaceutical applications include pressure and vacuum filters, filter candles, Nutsche filters, CIP filters, and fluidized bed dryers.
W.S. Tyler
http://www.wstyler.com/html/engineered_prod.html

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Eriez Magnetics

Metal Detector - Quick Ship Program
Eriez stocks eight E-Z Tec® metal detector aperture heights and three stainless steel, wash down conveyor widths for quick assembly and delivery. The variable speed conveyors are available in 12, 18 and 24-inch widths with a food-grade polypropylene belt. E-Z Tec metal detectors offer the highest level of protection against metal contamination. For more information, visit Eriez' website.
Editor's Pick product
 
Fette Compacting America Inc

Fette Compacting now offers the FE55, a tablet press that delivers unprecedented levels of productivity, flexibility and availability. The FE55 is clad in easily-detachable, FDA-certified high-performance polymer panels and offers 360-degree access. The FE55 has the ability to produce single- and double-layer tablets and direct pressing – the only machine of its compact size to offer all three capabilities. Click here for more info.
Editor's Pick product
 
Caron

Caron's Photostability Chambers ideal for forced degradation
Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. The 6540 series control light and temperature conditions. The 6545 series precisely control light, temperature and humidity. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. For more information visit, http://www.caronproducts.com/151.
Editor's Pick product
 
ASSMANN'S CHEMICAL FEED STATIONS

Assmann’s compact feed stations, ranging from 40 to 550 gallons, store small amounts of liquids and other chemicals.  The feed stations are lightweight, strong and easy to handle. Assmann linear polyethylene tanks are certified by NSF to NSF/ANSI Standard 61. Assmann’s High-density crosslink resin tanks also have NSF 61 Certification.
Assmann Corporation of America
http://www.assmann-usa.com/Chemical_Feed_Stations.htm
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Parker Hannifin

TOGETHER, WE CAN CREATE FAST-ACTING PHARMACEUTICAL MANUFACTURING SOLUTIONS.
From engineered products to custom technologies, from single-use components in disposable manufacturing and high performance sterile filtration to sealing components and liquid and gas flow control, from pharma to biopharma, Parker has a comprehensive portfolio. With Parker, you get a healthy dose of productivity and profitability. More info
Editor's Pick product
 
Schenck AccuRate

Feeder Designed for Pharmaceutical Processes
The Schenck AccuRate PureFeed® AP-300 feeder was designed specifically for pharmaceutical processes that include the following customer driven features, quick and easy disassembly, a dual arm agitation system for maximizing material handling versatility, and an FDA accepted EPDM feed hopper that is "disposable" and "recyclable." Feed rates from 0.5 to 150 Kg / hour are achievable. http://www.accuratefeeders.com/pharmfeeders.html
Editor's Pick product
 
Natoli

Laser Punch Inspection System
Utilizing dual laser technology, the advanced LVS 500 system provides immediate non-contact inspection of punches, and interfaces with the powerful Tool Management II (TM-II) database application for automatic data storage and analysis. Virtually maintenance-free and developed specifically for tablet manufacturers, the LVS is the most advanced punch inspection system available today. Schedule a free webinar now! http://www.natoli.com/LVS-PT.html
Editor's Pick product
 
Jost Chemical Co

Jost Chemical Co. understands the product demands of the pharmaceutical market. Specifically, Jost’s product development department works with our customers to meet new product requirements and to develop a DMF, ASME or CEP. As an FDA registered manufacturing site that operates under bulk pharmaceutical cGMP’s, Jost combines the required technical support and 27 years of manufacturing experience to supply high purity inorganic salts to the pharmaceutical market.
http://www.jostchemical.com/pharmaceutical.html
Editor's Pick product
 
CEIA USA

CEIA THS/PH21N Metal Detection Systems feature extremely high detection sensitivity towards contaminating metals, whether ferrous, non-ferrous or stainless steel, even when these are present in very small quantities. Once a contamination is detected, the system rejects the identified material. The system's fail safe operation monitors the opening and closing of the ejection flap through a redundant conformation sensor.
http://www.ceia.net/industrial/ap_pharmaceutical.aspx?type=pharma
Editor's Pick product
 
Meissner

The UltraSnap™ filter assembly conveniently secures multiple pre and final filters into a single-use filtration system for plug and play use. This configurable system is optimized for clarification through sterile filtration applications and effectively makes the scale of single-use filters unlimited. Designed with the flexibility to incorporate UltraCap® H.D. filter capsules from 10 inches through 50 inches, UltraSnap™ assemblies maximize processing and scale-up possibilities.
http://www.meissner.com/products/ultracap/ultrasnap.asp
Editor's Pick product
 
Rommelag

Rommelag®'s Bottelpack® Blow/Fill/Seal Advanced Aseptic liquid filling technology is a standard for producing SVP products throughout the world. The bottelpack® 4010M rotary Blow/Fill/Seal technology is the most efficient and has the highest aseptic assurance from any Blow/Fill/Seal system, fully capable to produce aseptic suspensions and emulsions. The bottelpack®4010M has SVP filling speeds of 250-500 per min depending on container size. http://www.rommelag.com/files/datasheet/ datasheet_bp4010M_de_en_07.pdf
Editor's Pick product
 
Cambridge Major Labs

(CML) is a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries. CML produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacture. CML boasts an impeccable reputation for delivering some of the most challenging projects, while meeting the tightest timelines. http://www.c-mlabs.com
Editor's Pick product
 
Watson Marlow

At Interphex 2012, Watson-Marlow Pumps Group is featuring their Flexicon products for high purity liquid aseptic filling, Watson-Marlow precise and reliable peristaltic pumps for biopharmaceutical applications, and Pureweld Tubing, a weldable tube designed for high purity and secure peristaltic pumping. Visit booths 2833 and 3033 for more information.
http://www.watson-marlow.com/us/Industry-homepage/Biopharmaceutical-industry-home
Editor's Pick product
   
Wirecrafters

WireCrafters manufactures wire partitions for security and storage of controlled substances Class III, IV and V. Wire partition cages come flush to floor with self-closing and self-latching doors. These cages meet DEA regulations for Section 1301:72.
http://www.wirecrafters.com/Drug-and-Pharmacy-Storage/p-13-Drug-Storage-DEA-Cages-Pharmacy-Storage.html
Editor's Pick product
 
Product Announcements
  • Emerson Process Management's Measurement Validation Diagnostic is now available on the Rosemount 848T Foundation fieldbus temperature transmitter.
  • The Mogensen Sizer from Almo Process Technology has been updated with redesigned output ports, vibration system, tensioning system, and dust cover.
  • Cryopak’s TimeSaver CRT Pre-Qualified Shipper keeps products between 20–24 °C for 24 hours.
  • Rockwell Automation's Allen-Bradley Kinetix 350 single-axis EtherNet/IP servo drive lowers the cost to deploy integrated motion on low-axis machines found in applications such as indexing tables and case packers.
  • Omega Design Corporation's LCX Bottle Unscrambler features patented rotary cam pockets and can handle over 300 bottles per minute.
  • Freeman Technology released a new software version for its FT4 Powder Rheometer featuring an enhanced display of real-time test information.

Calendar of Events
  • April 16–18: IVT's 13th Annual Computer and Software Validation Conference (San Diego, CA). This event features current global regulations and best practices delivered by industry experts.
  • April 16–18: The 2012 PDA Annual Meeting (Phoenix, AZ) focuses on innovation, offers networking opportunities, and provides a forum to influence the advancement of science and regulation in the industry.
  • April 24–25: ExcipientFest Americas (San Juan, Puerto Rico). This event features technical talks on excipient technology, new drug applications, and regulatory issues.
  • May 1–3: INTERPHEX 2012 (New York, NY). This premier exhibition for pharmaceutical manufacturing features the latest in automation systems, instruments, controls, processing, packaging, contracting products and services, and everything you need to run a laboratory or production facility.
  • May 3–5: 3rd Pharma Bangladesh International Expo (Dhaka, Bangladesh). This expo features pharmaceutical raw materials, active ingredients, processing machinery, packaging machinery, equipment, and related services.

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PharmTech Poll: Biologics Manufacturing

What has been the most significant development in biologic-based drug manufacturing over the past 10 years?

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