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Validating Solid Dosage Manufacturing
Processes, Equipment and Facilities
PharmaSys
offers more than just qualification and validation services for solid dosage
manufacturing processes, equipment, and facilities.
We offer
extensive pharmaceutical manufacturing technology and regulatory experience to
get your project completed in a faster and less costly manner than using
internal people or other vendors.
We provide:
for the following
solid dosage
manufacturing processes:
Our highly-trained and
experienced consultants will use our patented
FastVal™
methodology, a risk based approach, consistent with FDA's current thinking on
compliance, to minimize cost and effort, focus on critical parameters and
fully meet expectations of
the FDA and other regulatory authorities.
Our list of
experience is far too large for a webpage but some of the solid
dosage manufacturing technologies that we've validated are listed below:
Solid Dosage
Manufacturing Technologies
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Fluid Bed Drying
Fluid Bed Coating
Top-spray Granulation
Bottom Spray Granulation
Continuous Fluid Bed Granulation
Fluid Bed Pelletizing
Wet
Granulation (low/high shear and spray)
Microwave
Granulation |
Milling and Sieving Technologies (Comil, Glatt)
Intermediate bulk containers (IBCs) and powder handling/moving equipment
Drum and container blending, double-cone mixers and V-blenders
Spray Drying
Tray Drying
Automated
Dispensing System
Wash-in-Place &
Clean-in-Place |
Tableting, Encapsulation
& Coating Technologies
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Tablet
Pressing
Traditional
Encapsulation
Soft Gel
Encapsulation
Metal Detectors
Check-Weighers
Tablet and
Capsule Printing |
Laser Tablet
Drills
Mechanical Tablet Drills
Pan Coating
Drum Coating
Fluid Bed &
Spouted Bed Coating
Wash-in-Place & Clean-in-Place |
Packaging
Technologies
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Blister Packaging
Bottle Packaging
Sachet
Packaging |
Vision
Systems
Video Jet Printing and
Inspection
Slat Fillers, Cottoners, Labelers, Inserters, Outserters, Cartoners,
Erectors, etc |
Environmental and
Support Systems
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Building
Automation and Control Systems (BAS & BMS)
Warehouses
Solvent
delivery systems
Process , USP and WFI water systems
Compressed gasses
Compressed
air
Electrical
Systems
Plant
Steam and Clean Steam
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HVAC
systems
Room
qualifications and air quality monitoring
Temperature &
relative humidity mapping
Portable
storage facilities
Barrier
Isolators /Glove Boxes
Fume
Hoods
Glass
Washers
Part
Washers |
Mission Critical Systems
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ERP Systems
CAPA Systems
Employee Training Systems
Computerized Maintenance Management Systems
Document Management Systems |
MES Systems
Quality Management Systems
Statistical Process Analysis Systems
Computerized Calibration Management Systems |
QC Laboratory Equipment and Systems
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LIMS
HP/LC
HP/GC
FTIR Spectrometry
UV/VIS Spectrometry
Capillary
Electrophoresis
Ion
Chromatography
Microplate
Readers
Thin Layer
Chromatography
Scales, pH/ORP/C Meter
Microscopes
Inductively Coupled
Plasma (ICP) Analyzers |
Chromatography Data Systems (CDS)
TOC Analyzers
Autosamplers
Titrators
Gas
Samplers,
Microbial Air Samplers, Anemometers, &
Aerosol Photometers
Moisture
Analyzers
Density Meters
&Tapped Density Testers
LC/MS Systems
GC/MS Systems
Glass Washers
Dryers, Ovens, Refrigerators, Freezers, &
Autoclaves
Incubators & Stability Chambers |
We have a
flawless reputation of providing timely, cost effective solutions to our
customer's compliance challenges. To receive the highest quality service
conducted with the strictest confidentiality, complete and submit the form provided below:
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