Pharma-Bio Serv - Chemical and Microbiology Laboratory Support

By: Pharma-bio Serv  05/12/2011
Keywords: Microbiology, cleaning validation, Sanitizing Agents

  • Methods Development
  • Methods Transfer
  • Methods Optimization
  • Test Specifications
  • Environmental Monitoring
  • Bioburden Control
  • Investigations / CAPAs
  • SOPs development and training in Compliance with USP, EP, JP and FDA Guidelines
  • Methods Transfer and Validation
  • Sanitizing Agents Studies
  • Recovery Studies
  • Chemical Analysis (Bench Support)
  • Laboratory Equipment Qualification
  • Microbiology Training Modules
  • Chemical Qualitative/Quantitative Analysis of Raw Materials, Finished Goods and Stability
  • Empower, Millennium Systems
    • CVS
    • Project Manager
    • IOPQ
    • On-Site Trainings
    • Custom Programming (Tool kit)
    • Custom Fields
  • Laboratory Informatics Validation
  • High Performance Liquid Chromatographs (HPLC)
  • Gas Chromatographs
  • Microplate Readers
  • UV / Visible Spectrophotometers
  • Total Organic Carbon (TOC)
  • Near IR
  • Data and Acquisition Systems
  • Quality Control Testing
  • Microbiology Services (Scienzalabs)

Pharmaceutical, Biotechnology, Medical Device, Bulk Manufacturing Industries (Finished Product, Packaging, Stability, API, Raw Materials and Food Industry.):

  • Microbial Limits Testing
  • USP Organisms
  • Microbial ID
  • Sterility Testing
  • LAL Testing
  • Anti-microbial Effectiveness Test
  • Media Preparation
  • Environmental Testing and Monitoring
  • Particles Matter Identification
  • Water Testing
  • Cleaning Validation Testing
  • Bioburden Analysis
  • Swab Analysis

Food Industry:

  • Disinfectant Validation
  • Sanitization
  • Environmental Monitoring
  • Microbial Testing and Identification

Others:

  • Stability Storage
  • Stability Protocol Development
  • Compress Air Sampling and Testing
  • Disinfectant Validation
  • Sanitization
  • Media Preparation
  • Methods Verification & Revision
  • Methods Development
  • Methods Validation
  • On Site Pick Up

Keywords: cleaning validation, Microbiology, Sanitizing Agents

Other products and services from Pharma-bio Serv

05/12/2011

Pharma-Bio Serv - Services

Once product has been transferred to manufacturing, we also support the manufacturing processes to maintain its state of control by implementing the latest practices, such as Process Excellence and Risk Management tools. Pharma-Bio Serv offers solutions to the Pharmaceutical, Biotechnology, Medical Devices, Food, and Chemical Industries by providing comprehensive range of services to ensure regulatory compliance to our clients.


05/12/2011

Pharma-Bio Serv - Commissioning Qualification and Validation

Manufacturing Process Validation: Bio, Vaccines, Pharma, Med Devices, Consumer Products. Interpretation and Application of Quality Risk Management Guidelines. Manufacturing and Packaging Equipment Qualification. Active Drug Solubilities and Sampling. New Approaches to Cleaning Validation.


05/12/2011

Pharma-Bio Serv - Computer Systems Validation

Company Policies must be in place to establish the systems methodology to computer validation, combined with a systems based and risk management approach. Computer Systems and Software Validation is a requirement of the FDA 21 CFR and EMEA. 21 CFR Part 11 Corrective Action Plans. Development Test Plans & Report. Source Code Review and Testing.