Services we offer:
Cleanroom Certification
Environmental Monitoring
Environmental Monitoring
Cleanroom and laminar flow certifications
Testing for Fume Hoods, Biological Safety Cabinets and Aseptic Isolators
Environmental Monitoring
Environmental Monitoring
Environmental Monitoring
Test bioburden for verification of alert and action limits for cGMP and USP 797
Equipment Calibration
Environmental Monitoring
USP 797 & 800 Consulting
ISO 17025 calibrations for lab equipment
Repairs on lab equipment
USP 797 & 800 Consulting
USP 797 & 800 Consulting
USP 797 & 800 Consulting
Design Qualifications for new facilities
SOP's and programs to assist with preparing a pharmacy for USP 797 or USP 800 compounding
Cleanroom Cleaning
USP 797 & 800 Consulting
Cleanroom Cleaning
Cleaning for cGMP facilities, USP 797 Compounding Pharmacies for viable and non viable particles
Training
USP 797 & 800 Consulting
Cleanroom Cleaning
Custom training classes for aseptic gowning, aseptic technique, cleanroom protocol and cleaning
Development & Operations
Commissioning, Qualification, & Validation
Commissioning, Qualification, & Validation
Product and Process Development
Process Engineering
Commissioning, Qualification, & Validation
Commissioning, Qualification, & Validation
Commissioning, Qualification, & Validation
Validation Master Planning
Process Validation & IQ,OQ,PQ
Strategy, Planning, & Execution
Commissioning, Qualification, & Validation
Strategy, Planning, & Execution
Program and Product Management
Due Diligence