How Can We Improve Dissolution Testing for Transdermals?
US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments’ suitability for this application.
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Addressing Rouge in Biopharmaceutical
Manufacturing Systems
Rouge occurs in most biopharmaceutical facilities. The author recommends procedures that facilities should have in place for cleaning, derouging, and passivating new equipment.
>>Coming Soon: For an examination of egg- and cell-based methods of manufacturing influenza vaccine, look for the cover story in the October issue of Pharmaceutical Technology.
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Alfa Laval’s (Lund, Sweden) magnetic mixer is designed to provide high yields and reduce operating costs.
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The E Series of pneumatic solenoid valves from Gems Sensors and Controls (Plainville, CT) were designed for air and dry-gas applications such as in printing machinery, sorting equipment, automated packaging equipment, and air-monitoring systems.
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OPTIMA GROUP pharma
See the Inova SV125 fully automatic filling and closing machine for nested disposable syringes in the Optima Group Booth at this year's Pack Expo International Show, Booth N-4606. Format range up to 50ml with an output of 10,000 syringes per hour is achievable with the 5-lane model. Stop by Booth N-4606 at Pack Expo to view the machine first hand.
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Midwesco's Pleat+Plus® filter
Midwesco's Pleat+Plus® filter elements can increase the filtration surface area in your baghouse system by significantly reducing the air-to-cloth ratios.
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Kavon Filters
Fluid-bed dryer bags Kavon provides custom replacement fluid-bed dryer bags for US and European equipment models. The bags are appropriate for wet granulation, dry filtration, and wet and dry coating applications. The company offers flexible 1-4-bag systems in various fabrics choices and also repairs bags. Kavon Filter Products, Kavon Filter Products, Wall Township, NJ | www.kavonfilter.com | tel. 732.938.3135
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Platinum-Cured Silicone Hose for Purity
APSH braid-reinforced silicone hose is manufactured in an ISO-certified Class 7 clean room and meets USP Class VI, FDA, ISO, EP, and 3A standards. It offers flexibility and a wide temperature range for critical applications. Sterilizable, lot traceable, and stocked for quick delivery. Made in USA. AdvantaPureŽ
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How to Respond to (and Avoid) FDA 483s
Learn the ten best practices for formulating an effective 483 response. This article shows common observations and provides checklist to make the15-day response time limit more manageable, methods for improving quality systems for controlled environments, and links for further reading and reference. Read the entire article at www.veriteq.com/contact/fda_483_paper.htm
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- Cognex’s (Natick, MA) DataMan 8000 Series of handheld industrial identification scanners offers advanced code-reading technology for reading 1D and 2D codes, regardless of size, quality, printing method, or surface.
- The FS-480 Series flow switches from Gems Sensors and Controls (Plainville, CT) are available with port sizes as large as 0.75 in. and are aimed at monitoring fluid systems’ high flow rates.
- Kimberly-Clark Professional’s (Dallas) Kimtech Pure G3 Sterling Nitrile Gloves are designed to combine the sensitivity of latex with the protection of nitrile.
- Munters’s (Amesbury, MA) HCD series of desiccant dehumidifiers is designed to dehumidify to low moisture levels efficiently, processing between 300 and 12,000 CFM of air.
- Tote Systems (Ft. Worth, TX) offers custom software that controls a full range of powder-handling operations to ensure that content within each individual bin, bin inverter, blender, and discharge station meets standards for product integrity, ingredient balance, and volume.
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- Sept. 21: Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs (web seminar). This session will explore the key factors to consider when outsourcing a stability program. It is crucial to have a clear understanding of the responsibilities and expectations of both parties to build a strong relationship with the contract service provider.
- Sept. 29–30: Biobusiness Network (Geneva). This two-day conference provides networking and private-partnering meetings for the leading companies in the biotechnology and pharmaceutical industries. Attendees will be able to find out firsthand about the latest partnering opportunities.
- Oct. 3–6: Innovation in Drug Delivery: From Preformulation to Development through Innovative Evaluation Process (Aix-en-Provence, France). This conference will trace the steps in the development of a new drug-delivery system from preformulation to formulation and industrial development, highlighting the role of precise tools for the characterization and evaluation of the systems at each level of the process.
- Oct. 4–6: Tablets and Capsules: Development, Manufacture, and Testing of Solid Oral Dosage Forms (Costa Mesa, CA). The course will cover formulation-design considerations for tablets and capsules and unit operations used in the manufacture of the solid oral dosage forms.
- Oct. 5–7: P-MEC (Paris). This convention for companies on the lookout for new manufacturing technologies and solutions offers partnering and networking opportunities and helps connect thousands of buyers and sellers of pharmaceutical machinery, equipment, and technology.
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