Newsletter | December 4, 2021

12.04.21 -- Aseptic Manufacturing Product Showcase

 

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

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Featured Products
Small Batch Pharmaceutical Aseptic Filling Systems

The needs of the pharmaceutical and biotechnology markets evolve rapidly as new breakthroughs in medical and pharmaceutical sciences allow the industry to improve treatments and outcomes. With these advances come opportunities to improve traditional processes that are stressed and proving inadequate in many cases to produce the next wave of patient-focused medicines.

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Automated Systems of Tacoma, Inc.
Oxygen Monitoring Of Sensitive Formulations

The need to monitor headspace oxygen levels in parenteral containers arises from the requirement to ensure the stability and potency of oxygen-sensitive product. LIGHTHOUSE offers complete solutions for (in-process control) oxygen monitoring of oxygen-sensitive formulations, from development to manufacturing and quality control.

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LIGHTHOUSE Instruments
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
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
Restricted Access Barriers For Aseptic Manufacturing

Restricted access barriers (RABs) were developed to enhance pharmaceutical aseptic processes carried out in conventional cleanrooms. Extract Technology RABs are designed to fully comply with our customers’ requirements for aseptic pharmaceutical processing.

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Dec Group
Pharmaceutical Facility Commissioning Services For Aseptic Manufacturing

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
Pharmaceutical Cleanroom Pipe Insulation: T-FIT Clean

Cleanroom pipe insulation designed for demanding cleanroom environments in pharmaceutical, biotech, and semiconductor manufacture.

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T-FIT
High Voltage Leak Testing

Nikka Densok USA offers complimentary feasibility testing for your container closure integrity testing (CCIT) project. Whether the need is for stability testing or initial inspection capability, Nikka’s high voltage leak testing (HVLD) systems are here to support your CCIT needs.

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Nikka Densok USA, Inc.
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
Pharmaceutical 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 solution for medium and low-speed solutions, but with very high requirements. Our speed range covers up to 9,000u/h. In this product range we can offer maximum benefits such as isolators for high containment solutions, open and closed restricted access barriers (oRABs and cRABs), in-process control (IPC) control with checkweighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.

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SP Scientific Products
Modular Cleanroom Design And Construction For Pharmaceutical Manufacturing Operations
Your future cleanroom is the most crucial asset within the entire manufacturing environment. It surrounds critical manufacturing processes where your pharma or biotech company makes its life-changing products. The investment you make in the cleanroom facility should reduce your manufacturing risk and guarantee your performance. AES is the cleanroom expert because it's the only thing we do. We have had a singular focus on providing the most flexible cleanroom technology solutions for over 35 years.
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AES Clean Technology, Inc.
FDA Registered Cleaning Detergents

Q: What Alconox Inc. products are listed and FDA registered detergents?

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Alconox Inc.
Airnet II And IIs Remote Particle Sensors: Two Channels

A simple and cost-effective way to monitor your cleanroom, the Airnet II Air Particle Sensor provides unparalleled performance with data transmission capabilities for remote monitoring.

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Particle Measuring Systems
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 (RABS unit), change parts for 13 mm and 20 mm caps, 2 mL, 5 mL, 10 mL, 30 mL, 50 mL, and 100 mL vials, tray loader, system built 2015, installed 2016 and unused.
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Federal Equipment Company
Aerotrak 9510 Particle Counter 0.5µm@1 cfm

The TSI AEROTRAK 9510 Portable Particle Counter offers best-in-class features and versatility. The Model 9510 provides a 1.0 CFM (28.3 L/min) flow with 0.5 µm sensitivity.

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TSI Incorporated
T2620 Pharmaceutical Serialization System For Aseptic Products

Compact, fully integrated system for marking and verification of pharmaceutical track and trace products.

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Mettler-Toledo Product Inspection
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.
Flashblend Powder/Liquid Mixing Systems

Dispersing powders into liquids and creating a consistent homogeneous product, time after time, is one of the most difficult of all mixing applications. To satisfy this need Silverson has developed the Flashblend, a high-shear system for rapid incorporation of a wide range of powders, including problematic gums and thickeners.

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Silverson Machines, Inc.
Pharmaceutical Mixers For Sterile/Aseptic Manufacturing

Ross serves the requirements of the pharmaceutical industry in virtually every industrialized country around the world. Typical applications include mixing, blending, particle size reduction, emulsification, homogenization, powder induction, vacuum processing, and more.

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Charles Ross and Son Company
Pharmaceutical Aseptic Filling Isolator: IsoSphere
The IsoSphere-AF is a positive pressure unidirectional airflow isolator or restricted access barrier (RABS) for small-, medium-, and large-volume aseptic filling.
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Flow Sciences Inc.
Compounding Pharmacy Isolator
The PharmaGard ES PR797 Compounding Pharmacy Isolator creates a recirculating positive pressure ISO Class 5 clean air controlled environment for aseptic compounding of non-hazardous drugs guaranteed to meet USP 797 compliance requirements.
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NuAire, Inc.
Equipment Calibration Software For Life Sciences

MasterControl software automates equipment calibration processes. It helps manufacturers improve their performance and ensure audit-readiness.

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MasterControl, Inc.