Do Particulate-Inspection Methods Need Scrutiny?
Recent recalls, including that of American Regent’s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.
|
Manual and Automated Filling of Powder in Capsules for Clinical Trials
Filling active ingredients directly into capsules is probably the quickest option for entering clinical trials. This case study compares manual and automated methods of capsule filling.
>>Coming Soon: For a look at technological innovation in facility design and operation in high-potency manufacturing, look for the Pharma Ingredients Report in the June issue of Pharmaceutical Technology.
|
 |
Multitasking in the laboratory
The Inova SV from Optima Group pharma, fills both vials and prefilled syringes and can switch between different dosing systems. The line covers a format range between 0.5 and 50ml for syringes. The dosing volumes range between 0.1 and 50ml. For vials the filling volume is 20ml. Maximum output of 5,000 units per hour with two lane operation.  www.optima-pharma.com |
|
| |
Natoli Die Table Segments
Proud to be the only authorized manufacturer of Fette die table segments, Natoli manufactures standard round, special shape, multi-tip, and carbide-lined die segments of exceptional quality – all available for international delivery.
 http://natoli.com/PunchesDies/ToolConfigurations/Fette-Die-Table-Segment.aspx |
|
| |
Biocontainer "Standards Guide"@ www.meissner.com
Meissner's repository of ready-to-use single-use TepoFlex® biocontainer assembly designs can be downloaded from Meissner.com. These "standards" can be purchased for 3-4 week delivery, or used as the basis to streamline the design process for customized assemblies. Configurations include 2D end-ported, 2D face-ported and 3D configurations.
 http://www.meissner.com/products/onetouch/tepoflex.asp
|
|
| |
RoTab T R & D Tablet Press The portable RoTab T offers precise scale-up to free up production machines from trials. The cGMP design enables easy validation for the production of small tablet batches and pre-clinical studies.
- automatic tablet weight regulation via filling depth
- seamless RPM adjustment for die table and Optifiller
- servo-driven compression roll stations
- optional servo-driven tablet hardness adjustment
- automatic punch lubrication with adjustable intervals
 http://www.fette-compacting.com/next |
|
| |
|
L.B. Bohle’s New U.S. Service Center for Tablet Coater Training and Product Trials L.B. Bohle now provides product trials and training on the Bohle Tablet Coater at its U.S. Service Center in Warminster, Pa. Working with Bohle’s expert staff in the 2,000-square-foot Service Center, companies can train their personnel on:
- Operating the Bohle Tablet Coater;
- Process development and optimization;
- Containment application demos;
- Blending (lab and production scale); and
- Milling (cone mill, hammer mill).
 http://www.bohle-tablet-coater.com/us-service-center.html |
|
| |
|
GelJacket™ CO2 Incubator
Caron’s new 10 cu. ft. GelJacket Benchtop IR-CO2 Incubator is the most innovative technological advancement for cell culture incubators in decades. GelJacket is active gel insulation, located in every incubator wall. GelJacket has thermal advantages far surpassing any other CO2 incubator. Units come standard with an IR sensor, controlled humidity, decontamination cycle and more! To learn more visit.
 www.caronproducts.com/geljacke
|
|
| |
|
Bosch
The PreVAS family of aseptic single-use dosing systems by Bosch represents a new chapter in dosing system technology. PreVAS is the first completely pre-assembled, and pre-sterilized dosing system available for the clinical and production pharmaceutical and biotech filling market that is supplied with supporting validation documentation.
 http://boschpackagingpharmana.wordpress.com/prevas
|
|
| |
|
PREVENT CHEMICAL SPILLS WITH DOUBLE WALL TANKS
W.Assmann cylindrical double wall tanks provide protection against hazardous chemical spills. Assmann’s molding process provides a heavier-top sidewall and dome to prevent dome collapse, with primary inner tank and secondary locked on outer tank ensuring against chemical spills.
High-density crosslinked polyethylene or FDA compliant and NSF Certified linear polyethylene tanks offer sizes from 20 to 6550 U.S. gallons. Assmann is ISO 9001:2008 certified.
 http://www.assmann-usa.com/Double_Wall_Tanks.htm
|
|
| |
|
Alleghany Bradford Corporation
The Automated Sampling System designed and manufactured by Allegheny Bradford is easy to install, operate and maintain. Continuous flow design ensures constant sterility that supports CIP and SIP. Features a double-tubesheet heat exchanger for leak detection and Pitot / Venturi tube design. PLC with HMI, Ethernet/USB/Card data logging. The system provides instant sample availability.
 www.alleghenybradford.com
|
|
| |
|
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.
Visit us at Interfex, booth 2057.  http://www.wstyler.com/html/engineered_prod.html
|
|
|
 |
- The Quick-Clean series of rotary airlock valves from ACS Valves is designed to aid compliance with regulatory standards and reduce cleaning and sanitizing time.
- Bosch Packaging Systems offers its Sigpack RAx Stick Pack system for the primary and secondary packaging of free-flowing products.
- The new Powder Rheometer software from Freeman Technology includes a completely redesigned graphical user interface that improves the display of real-time test information.
- The uEye UI-5490HE camera from IDS can be integrated into systems for manufacturing quality control and microscopy applications.
- National Bulk Equipment’s fully integrated bulk-material handling system uses process communications to automate simultaneous batching of multiple chemical mixtures during a single processing operation.
|
 |
- Jun. 1–2: Sterile Pharmaceutical Dosage Forms (Bethesda, MD). This introductory two-day course on sterile dosage forms will address topics such as cleanroom facilities, environmental monitoring and control, sterilization principles, manufacturing unit operations, and aseptic filling.
- Jun. 13–15: Lyophilization Technology—Practical Application of the Scientific Principles (Los Angeles). Participants will gain a firm understanding of lyophilization equipment, including topics such as system operation, system components, system maintenance, system troubleshooting, qualification, and system validation.
- Jun. 15–16: Chemspec Europe 2011 (Geneva). Many of the world’s largest suppliers of fine and specialty chemicals and associated products and services attend Chemspec Europe, making the event a good opportunity to connect with vendors.
- Jun. 20–22: 10th Annual Biological Production Forum 2011 (Frankfurt). This well established event focuses on upstream and downstream processing for biological manufacturing, production, and cGMP specialists.
- Jun. 21–23: IVT’s 2nd Annual ACE (Philadelphia). This forum will include conferences on aseptic processing, cleaning validation, and environmental monitoring.
|
|
|
