Newsletter | September 11, 2021

09.11.21 -- Aseptic Manufacturing Product Showcase

 

Pharmaceutical Online’s Product Showcase — your trusted resource for featured equipment and services specific to the aseptic manufacturing space.

Pharmaceutical Filling And Closing System For Syringes, Cartridges, And Vials: SYFILL

SYFILL automatic filling and closing machines are suitable to process nested presterilized syringes, vials, and cartridges.

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GF
Container Closure Integrity Of Parenteral Products

The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

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PTI Packaging and Inspection Systems
Aseptic Filling Systems For High-Containment Applications
Dec offers filling lines for both liquids and solids for the aseptic fill/finish processes that require high-containment equipment.
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Dec Group
High-Voltage Leak Detection For Glass Vials: HDV-AT6

The HDV-AT6 pinhole inspector provides 100% inspection for glass vials with nondestructive leak testing.

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Nikka Densok USA, Inc.
Pharmaceutical Cleanroom Environmental Contamination Monitoring
Monitor your viable and nonviable particles according to the most recent regulatory requirements. Count, report, document, and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements.
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Particle Measuring Systems
Single-Use Aseptic Isolator: soloASEPTIC
The soloASEPTIC system has been designed to accommodate a variety of aseptic processes in a single-use disposable isolator. Allowing for flexibility in your facility, this system works around your needs.
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ILC Dover
Pharmaceutical Facility Commissioning Services

Having your commissioning agent (CxA) involved in the design phase brings value that is not realized until the project is finished. A CxA has been through many different configurations and knows what works, and what does not.

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CAI
Inline And In-Tank Mixer Homogenizers
Silverson Mixer Homogenizers are fast and efficient and are capable of producing a fine droplet or particle size, typically in the range of 2 to 5 microns. This degree of homogenization is suitable for the vast majority of products, such as creams and ointments, lotions, sauces, and flavor emulsions.
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Silverson Machines, Inc.
Headspace Oxygen Monitoring On A Prefilled Syringe Line Filling Oxygen-Sensitive Product
This application note describes how laser-based headspace analysis is used for the rapid nondestructive determination of headspace oxygen levels in prefilled syringes. Data are presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a prefilled syringe line filling oxygen-sensitive product, and 2) container closure testing of prefilled syringes.
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Lighthouse Instruments
Serialization For Pharmaceutical Bottles And Vials
Wipotec-OCS TQS-LI-Bottle is a solution for the serialization of individual pharmaceutical bottles by applying labels. The system is characterized by a very compact design in transport, applicable for track and trace serialization efforts worldwide.
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Wipotec-OCS
Aseptic Processor
Special aseptic processors are available for the manufacture of sterile products.
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Charles Ross and Son Company
Cleaning Detergent: Low-Foaming, High-Alkaline Liquid
Keylajet is a low-foaming, high-alkaline liquid designed for hard-to-clean soils, grit, grime, slime, grease, buffing compounds, oils, particulates, deposits, chemicals and solvents, mold releases, metal oxides, and more.
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Alconox Inc.
Single-Dose Blow/Fill/Seal Pharmaceutical Vials

Unit dose blow/fill/seal vials for one-time ophthalmic use have become an accepted international standard for pharmaceutical manufacturing and packaging. The ASEP-TECH Advantage is reflected in the development of formulations that no longer contain preservatives, minimizing the risk of allergic reactions for patients.

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Weiler Engineering, Inc.
Unused SP PennTech Complete Vial Filling Line

Unused SP PennTech inline mono-block vial filling line consisting of: Model RW-800 rotary vial washer, serial# RW81202, model PST-45/380 depyrogenation tunnel, serial# PST453801402, Model FSC6/AC inline vial filler, stopper, capper unit, serial# FSC61401, with six-head inline filling station, stopper inserter with bowl feeder, capper with bowl feeder, mounted inside restricted access barrier system (RABS).

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Federal Equipment Company
Aseptic Filling Systems For Sterile Injectables

The injectables market is a very demanding market, with high-standard requirements. i-Dositecno is offering a very high-standard system for medium- and low-speed solutions that have difficult requirements. Our speed range covers up to 9,000 u/h.

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SP Scientific Products
Infinity Glass Cleanroom Wall System For Aseptic Environments

When transparency is paramount, the AES infinity system provides the viewer with a close-up and very clear viewing experience, enabling interested personnel to see the process without entering the cleanroom environment. The AES infinity glass wall system is easily integrated with other wall systems.

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AES Clean Technology, Inc.
Vaccine API Weighing And Processing Glovebox Workstation

The Vaccine API Weighing and Processing Glovebox Workstation is designed to provide personnel and product protection during the weighing and manipulation (processing) of APIs, providing attenuation of breathing zone exposure down to concentration ranges corresponding with OEB 4 (Occupational Exposure Band 4).

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Flow Sciences Inc.
Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

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TSI Incorporated