INSIGHTS ON LIQUID DOSE MANUFACTURING
The Challenges Batch And Continuous Manufacturing Bring To Containment Product Design
Methods and techniques used in pharmaceutical manufacturing are broadly reviewed. There are two basic models of pharma manufacturing: batch and continuous. Both approaches are defined. It is concluded that both approaches have elements of the other. Generally speaking, many pharma manufacturing procedures are transitioning from the batch to the continuous approach.
Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product
This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.
Container Closure Integrity Testing Method Development
Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.
HPAPI Processing And Drying Suite For Operator And Product Protection
A two-part enclosure consisting of a single pass air flow glove box enclosure and a nitrogen purge enclosure was designed to provide protection to the operator and product.
Using Positive Controls In Container Closure Integrity Studies
This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.
Venting Fume Hood Base Cabinets — A Better Way
Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out.
Selection Criteria for Ribbon, Vertical, or Tumble Blenders
Among solid-solid blending systems, the three most common types are the horizontal ribbon blender, the cone screw vertical blender and the tumble blender. Aside from level of shear or ‘gentleness’, other factors help determine which type of blender will work most efficiently in a certain application. Following are some things to consider when choosing your blender.
8 Key Factors When Selecting A Powered Air-Purifying Respirator System
This white paper explores eight considerations in detail and could be helpful to EHS managers and supervisors looking to select a Powered Air-Purifying Respirator system for their particular application.
How The Extrusion Process Impacts The Quality Of Blow/Fill/Seal Products
A collaborative study involving Cardinal Health, Inc. and Air Dispersions Ltd. has been carried out to further the understanding of the extrusion process and its impact upon the quality of Blow/Fill/Seal product.
LIQUID DOSE MANUFACTURING SOLUTIONS
NuAire In-VitroCell™ ES Model NU-5820 CO2 Incubator
The In-VitroCell ES NU-5820 Microbiological CO2 Incubator features relative humidity (RH) control for cell lines prone to desiccation by utilizing a sensor that measures humidity in the chamber and injects 99.99% HEPA filtered vapor into the growth chamber to maintain setpoint.
GENiSYS Lab Vial Sealing System
AST's Vial Sealing System (VSS) is a benchtop, semi-automatic machine used for sealing or capping pharmaceutical vials and bottles with aluminum caps. The VSS provides complete and precise control of the container sealing or capping operations to ensure the highest quality vial seal. The system’s versatility allows for the processing of a wide range of vial or bottle sizes and finishes and is ideal for small batch processing of sterile pharmaceutical and biotechnology products.
CleanFlow – Clean Air Workstations
The CleanFlow is a unidirectional, positive pressure, laminar air flow workstation.
Used Bausch Stroebel Syringe Filling System: SFM 5110
Used Bausch & Stroebel pre fill syringe filling line, consisting of; Bausch & Stroebel denester, model SET 8090, serial# 53617 Bausch & Stroebel syringe filler, model SFM 5110, (5) head, with capper, control panel and vision inspection system, serial# 53610 Bausch & Stroebel plunger rod inserter, model ESS1001, rotary operation with hopper and reject, serial# 53562 Bossar Sealer, model BMK-2000S/PMP1, with manuals, 480 volts, with bar sealer, vision system, touchscreen controls, and reject, serial# 30077, unit built 2007 Newman Labeler, model NVS2, rotary operation, with label printer, visual inspection system, and reject, 110 volts, with controls, serial# 04105, unit built 2004 Videojet laser coder, with associated parts, Line built 2006 and delivered 2008, equipment is in excellent condition.
Sterile Fill/Finish Capabilities
AbbVie’s aseptic fill/finish vial line supports lyophilization for potent and biologics along with liquid fill vials. Our approach is based on commercial success that we then apply to find the right solution tailored to meet your product's needs.