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WHITE PAPERS & CASE STUDIES

  • Overcoming Challenges In Virus Removal
    Overcoming Challenges In Virus Removal

    Biotechnological and biological therapeutic products are often manufactured using materials of animal or human origin, which carry a risk of being contaminated with either known or unknown viruses.

  • Single-Use Technology: The Trust Factor
    Single-Use Technology: The Trust Factor

    What is missing today is trust. The axiom “trust but verify” is truer with single-use systems than in the past. The customer/supplier relationship required with single-use systems cannot be transactional, but must be a long term partnership for mutual success. This has to be built on a foundation of trust, and that is lacking today. For the end users, the implementation of single-use systems represents an outsourcing of critical operations, previously performed and controlled by their own people and quality management system.

  • Inspecting Powders - A New Opportunity
    Inspecting Powders - A New Opportunity

    Advances in powder flow measurement using shear cell technology now make it possible to consider this technique for both incoming inspection and final product acceptance. Why?

  • Case Study: Bag Handling, Check Sieving, Weigh System
    Case Study: Bag Handling, Check Sieving, Weigh System

    In this installation, materials are received in 50-pound bags and semi-bulk bags and are security screened for foreign objects while being conveyed to a weigh hopper, where they are automatically hatched in predetermined weights and discharged into process drums.

  • Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644
    Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644

    This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.

  • The Cost Of A Powder Stoppage
    The Cost Of A Powder Stoppage

    Operations managers cope with powder jams on a recurring basis. At least once a month, there may be a more significant event that brings production to a halt and seriously affects output for that day.

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PRODUCTS & SERVICES

Used Korsch 71 Station Tablet Press

Used Korsch 71 Station Tablet Press

One (1) used Korsch rotary tablet press, model XL800, 100 Kn main compression with 100 Kn pre-compression, 71 stations, "B" tooled, dual sided, 16 mm max tablet diameter, 18 mm max depth of fill with single layer, bi-layer capable with 16 mm max depth of fill, 10 mm max second layer depth of fill, speeds up to 766,800 tablets/hour single layer, 383,400 tablets/hour bi-layer, includes spare turret and control panel, serial# K1580006, built 2003.

Pharmaceutical Filling And Closing Equipment For Vials, Syringes And Cartridges

Pharmaceutical Filling And Closing Equipment For Vials, Syringes And Cartridges

The FXS Combi is an extremely flexible solution for pharmaceutical filing operations.

Automated Vial Inspection Equipment:  AIM 8 V

Automated Vial Inspection Equipment: AIM 8 V

The AIM 8 V inspection machine for sealed vials from 2 to 125 ml, up to 54.5 mm in diameter and 230 mm in height, detects particulates in liquids and cosmetic container defects at ranges up to 600 per minute.

Unused IMA Powder Filling System, MF400

Unused IMA Powder Filling System, MF400

One (1) Unused IMA aseptic microdoser powder filling line, model MF400, speeds up to 400 vials/minute depending on number of fill stations, currently set up with 2 filling stations, 20 - 32 mm vial diameter range, 40 - 75 mm vial height range, 20 mm stropper diameter with stopper bowl feeder, currently set up for 240 vials/minute at 1 grams doses and 60-80 vials/minute at 4 gram doses, unit mounted in isolator glovebox with external vacuum, machine# DH 1032, built 2014. Unit has had FAT and is unused.

Rapid Microbial Detection For Real-Time Pharmaceutical Water Monitoring

Rapid Microbial Detection For Real-Time Pharmaceutical Water Monitoring

“The IMD-W system is one of the first of its kind to respond to a call from the pharmaceutical industry for on-line water bioburden analysis (OWBA),” said JeffreyWeber, PAT project manager at Pfizer and one of the founding members of the OWBA workgroup. He added, “BioVigilant’s IMD-W system is a new complementary tool at our disposal, for trending the state of control of water systems in real time through continuous bioburden monitoring.”

Hydrogen Vapor Peroxide Bio-Decontamination Equipment

Hydrogen Vapor Peroxide Bio-Decontamination Equipment

The Bioquell Q-10 is a hydrogen peroxide vapor (HPV) bio-decontamination system which can be used to bio-decontaminate rooms, laboratories and hospital wards/units in a non-regulated environment.

Pharmaceutical Portable Cleanrooms

Pharmaceutical Portable Cleanrooms

Pharmaceutical Portable Cleanrooms are self-contained units used to upgrade existing or new cleanrooms to a Class 100 or (ISO-5), designed to be suspended from the ceiling or mounted on legs and casters for portable applications.  Custom Powder Systems offers custom sizes to fit available space or a standard size to meet cost requirements.

Pharmaceutical Powder Blending Equipment

Pharmaceutical Powder Blending Equipment

Dry powder blending of pharmaceuticals is simplified with bin blending that reduces blend times and requires no between batch cleanup. Since products contact only the bin, the benefits of total product containment, immediate product changeover and zero blender cleaning are realized. Pharmaceutical bin blending also eliminates airborne and cross-contamination, product segregation and spillage risks.

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