Newsletter | May 14, 2022

05.14.22 -- Quality Assurance Product Showcase

 

Pharmaceutical Online’s Product Showcase — your trusted resource for featured equipment and services specific to quality assurance in pharmaceutical manufacturing.

Featured Products
Vaporized Hydrogen Peroxide Biological Indicators

APEX Biological Indicator products are designed specifically for the pharmecutical and medical device industries utilizing H2O2 vapor sterilization. The stainless steel carrier is designed for use with today’s isolator and filling line applications.

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Mesa Laboratories
Cloud Based Manufacturing Execution System (MES)

Get from kickoff to first batch-run in days, not months.

Accelerate process design without any code
Put power in the hands of your team. With intuitive, no-code procedure and recipe authoring designed for process scientists and process engineers, your teams can configure Tempo without code.

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Apprentice
Coding And Verification System For Vials: KIV

The regulatory requirements regarding the traceability of pharmaceutical products are becoming more and more demanding. Cross-process solutions, which enable the tracking and identification of each filled and sealed vial, bring benefits not only in product safety and protection against counterfeiting. They also offer advantages for production itself, e.g. the possibility of logistically separating filling/sealing processes from labeling/packaging routines. With the KIV series, Syntegon offers an inline solution for coding and verifying vials that promises both high quality and high performance, and can easily be integrated in existing lines.

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Syntegon Pharma Technology Inc.
Cell Therapy Isolators For Pharmaceutical Manufacturing

Extract Technology’s Cell Therapy Isolators are designed to provide an ergonomic and practical alternative to traditional clean rooms for stringent cGMP and international regulations for the production of cells for clinical use.

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Dec Group
Out Of Specification (OOS) Software For Life Sciences

The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

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MasterControl, Inc.
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
Pharmaceutical Metal Detection Systems: Tablets & Capsules

Designed to meet the exacting standards and regulations of the pharmaceutical industry, METTLER TOLEDO Safeline pharmaceutical metal detectors provide the ultimate solution in fully integrated product inspection and rejection systems for tablets, capsules, powders and granules. Our metal detection systems are designed to detect all metal contaminant types, including ferrous, non-ferrous and even the most difficult-to-detect non-magnetic stainless steels.

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Mettler-Toledo Product Inspection
Tablet Compression Tooling

A global leader in manufacturing, Natoli Engineering Company delivers superior tablet compression tooling. Every punch and die is produced from quarantined steel and tested for hardness and exact chemical composition by stringent quality specifications. 

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Natoli Engineering Company, Inc.
Used IMA High Speed Pharmaceutical Checkweigher – Precisa 120

Used IMA capsule checkweigher, model Precisa 120, designed to handle hard gelatine capsules, rated up to 120,000 capsules/hour, capsule size range from 40 mg to 2000 mg, +/- 2 mg accuracy, serial# PA1031, built 1999.

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Federal Equipment Company
Pfeiffer Vacuum Container Closure Integrity Testing Solutions

Pfeiffer Vacuum offers a wide range of different leak testing methods to address the multitude of challenges within the pharmaceutical industry as there is no one solution that fits all different challenges connected to a specific product.

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Pfeiffer Vacuum Inc.
Low-Foaming Liquid Acid Cleaner

Low foaming acid cleaner and rinse for high performance results from your cleaning machinery. Use to pass your cleaning validation tests for lab accreditation and plant inspection approval. 

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Alconox Inc.
Vision Inspection System For Pharmaceutical IV Bags

The new automatic high speed bag inspection machines are specially designed to treat soft IV bags. It offers offer the ideal solution to ensure parenteral products are essentially free of foreign particles, that can affect their sterility.

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GF
O2 Headspace Monitoring For Parenteral Drugs

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-senstive formulations, from Development to Manufacturing and Quality Control. 

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Lighthouse Instruments
cGMP Infinity Glass Cleanroom Wall System

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.
Energy And Sustainability Strategies

Translate your sustainability ambitions into action with our end-to-end suite of solutions Whether you are looking to upgrade your buildings and systems to maximize energy efficiency and minimize carbon footprint, launch and manage coordinated portfolio-wide sustainability programs, or invest in the infrastructure you need to make your sustainability ambitions a reality, our deep bench of “green” facilities experts help you adopt energy and sustainability strategies that reduce your carbon footprint and appeal to environmentally conscious workers. And, we can deliver renewable and alternative energy sources to power your facilities.

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JLL
Quality, Compliance, And Regulatory Services

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

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CAI
360° Pharmaceutical Inspection For Semi-Automatic Aggregation

TQS-CP-Bottle is designed for the perfect integration in bottle or vial production lines. The system can be set up directly at the outlet of any conventional labeling machine to verify the previously serialised labels on individual cylindrical containers via an omnidirectional, 360° inspection.

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Wipotec-OCS
Aseptic Genderless Connectors

The AseptiQuik family of Connectors provide quick and easy sterile connections, even in non-sterile environments — a critical capability for biopharmaceutical manufacturers. The connectors robust construction provides enhanced user confidence and reliable performance without the need for clamps, fixtures or tube welders. The innovative sterile connector technology allows manufacturers to make aseptic connections quickly and easily between single-use bag systems, tube sets and/or stainless process equipment.

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Qosina Corporation
High Voltage Leak Testing

Nikka Densok USA offers complimentary feasibility testing for your CCIT project. Whether the need is for stability testing or initial inspection capability, Nikka’s HVLD systems are here to support your CCIT needs.

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Nikka Densok USA, Inc.
ASEPTiCell - Robotic Multi-Format Filling & Closing System

AST’s ASEPTiCell is a flexible fill/finish systems that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

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Automated Systems of Tacoma, Inc.
Contract Packaging Services For Probiotics

Sachet is a packaging format that meets the demands of probiotic consumers and manufacturers alike.

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Ropack Pharma Solutions
Containment Split Butterfly Valves

ChargePoint Technology’s PharmaSafe transfer valve range offers the highest levels of operator protection through validated containment performance.

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Chargepoint Technology
DS3 Size Pharmaceutical Tablet Tooling

DS3 size tooling is available in a wide variety of standard shapes and can also be customized to your specific application and design. The upper punch and lower punch are available in standard or advanced tool steel, to help you ensure the best in performance and production based on your tablet needs. Dies can be manufactured with standard steel, or in a wide variety of high-performance advanced steel options.

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Wilson Tool
Microbial Air Sampler: MiniCapt Mobile

The MiniCapt Mobile Microbial Air Sampler from Particle Measuring Systems (PMS) is an innovative, light and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.

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Particle Measuring Systems
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
Pharmaceutical Feeders For Oral Solid Dose Manufacturing

No two process applications are the same, and Coperion K-Tron offers the widest range of feeding solutions in the industry. From screw feeders to vibratory feeders, bulk solids pumps, weigh belts, liquid feeders and flow meters, all feeders are offered in a variety of configurations, which can be combined to create an optimal solution for any application.

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Coperion & Coperion K-Tron
SP Hull Depyrogenation Tunnels

Fully Automatic Sterilization
There are several different methods of inactivating pyrogens, including bacterial endotoxin’s, on vial surfaces. The most common and effective way is through dry heating to above 250°C, and both manually loaded ovens for smaller batch sizes and continuous production depyrogenation tunnels have been used. SP provides a range of fully automatic sterilization/depyrogenate and tunnels for vials, in a variety of sizes including production rates in excess of 700 vials per minute. At just five feet in length, our smallest depyrogenation tunnel is ideally suited for laboratory and small batch applications.

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SP Scientific Products
Hygienic Weigh Module For Tank, Vessel And Hopper Weighing

Contamination-Free Hygienic Weigh Module

The SWB805 is a fully approved hygienic weigh module for food and pharmaceutical applications. The design is optimized for avoiding contamination and meets compliance requirements in harsh environments. It is designed according to EHEDG guidelines and is NSF and GMP approved.

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Mettler Toledo, LLC