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Vial Filling Equipment
GLE maintains an extensive library of standard User Requirements Documents, Procurement Specifications, Factory Acceptance Testing, Site Acceptance Testing, Installation & Operational Qualification Documents for many equipment types that can be readily adapted to the desired Client content and format. GLE also provides the Client a current detailed understanding of many design standards and requirements affecting equipment safety, design and construction. These include EN Standards, GAMP4, 21CFR Pt.11, FDA Guidelines On General Principles Of Process Validation, ASME BPE Standards and ISO Standards.
Vial Filling Equipment
 Vial Washing
Vial Depyrogenation / Sterilizing Tunnels
Vial Filling
 > 2mL to 100mL up to 400 vials per minute
> Time Pressure Filling
> Positive Displacement Filling
> Peristaltic Filling
> Rolling Diaphragm Filling
Vial Capping
Vial Inspection (Automatic & Manual)
Lyophilizers
> 10M2, 25M2, 40M2 & 50M2
Lyophilizer Loading / Unloading System
> Loading Accumulation Tables
> Autoloaders (Fixed & Mobile)
> Unloading Accumulation Tables
> Unloading Accumulation Buffer
Vial Capping
Vial ID & ID Verification
Vial Tray Loading
Syringe Filling Equipment
Syringe Washing & Siliconization
Syringe Depyrogenation & Sterilization
Syringes Tub (Hypak) Transfer Into Filling
> Manual Wipe & Pass Through
> Continuous VHP Sanitization
> VHP Batch Sanitization
Syringe Filling
> 0.5mL to 10mL up to 400 syringes per minute
> Positive Displacement Filling
Syringe Inspection (Automatic)
Syringe ID & ID Verification
Syringe Labeling
Rondo Tray Loading / Unloading
Denesting / Renesting
Component Preparation & Key Utility Sysytems:
Stopper Processors
> Up to 240 Liters
Autoclaves
> 0.5M3 to 10M3
CIP Skids
> Up To 15,000 Ltrs.
Dry Heat Ovens
Packaging Equipment:
Thermoformers
Cartoner
Stretch Banders
Case Packers
Pick & Place Loading Robots
Component Handling / Application Machines
Tablet Filling Systems
Bulk Tablet Handling / Containment
Bottle Labeling
Bottle Capping
Product Assembly Device Equipment
Containment Equipment:
Sub Division Facilities
Reactor Charging
Dryer Offloading
Milling
Material Transfer & WiP Containment
Controls and SCADA:
SCADA Application to Processing Lines
21 CFR Part 11 Guidance and Application
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