Deliverables

  • Author protocols and final reports for validation processes
  • Validation Master Plan
  • User requirement specifications
  • Design specifications, facilities
  • Identification of Critical Operating Parameters and defining Acceptance Criteria
  • Protocol execution
  • Technical transfer assistance
  • Project management and tracking
  • Implementation of a Risk-Based Validation Program
  • Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • Facility and critical utility system commissioning

Benefits

  • Highly qualified and experienced associates
  • Reliable service
  • Tailored to customer’s needs
  • Cost effective
  • Quality driven
  • Adherence to FDA and other regulatory agency compliance
  • Knowledge of current validation and compliance topics by keeping abreast through industry conferences by organizations such as IVT, ISPE, PDA and AAMI
  • Ability to satisfy regulatory requirements enforced by various regulatory bodies which include ISO, MHRA, FDA, USP and EMEA

Need a Quick Quote?

Please email your specific request, including name, company name, and desired time frame to info@lexamed.net.

Medical Device and Pharmaceutical Validation Services

LexaMed offers validation services in the pharmaceutical and medical device industries, including process, product, facility, equipment and analytical methods. Projects have been scoped at more than US$15M and ranging in size from qualification of a single piece of equipment to complete turnkey validation of equipment, critical utilities, and projects for facilities located both domestically and internationally.

Capabilities

Our team of validation associates has expertise in all aspects of pharmaceutical and medical device operations, including, but not limited to:

Process Equipment Qualifications

Qualification includes URS preparation, FAT, SAT, IQ, OQ, PQ, design qualification and impact assessment

  • Temperature controlled equipment: autoclaves, refrigerators, freezers, environmental and stability chambers
  • Packaging equipment
  • Aseptic manufacturing equipment
  • Solid dosage form equipment
  • Liquid filling equipment

Clean Room Qualifications including automated controls systems (SCADA, BMS)
Testing includes:

  • Temperature and relative humidity mapping and monitoring
  • Environmental monitoring master plan
  • Viable and non-viable particulate testings

Cleaning Validations

Utilize equipment cleaning procedures to remove residues to levels of acceptability by:

  • Establishment of residual limits and acceptance criteria
  • Sampling selection
  • Analytical method selection

Cleaning validation studies conducted via analysis and sample recovery methods include bioburden,
detergent residuals, drug substand/product residuals, protein. Equipment includes blending tanks,
fillers and tablet compression, sonic cleaners, medical devices
and components.

Sterilization Methods

  • Methods include EO, Steam, VHP, Radiation, UV, Ozone, Pulsed-Light, Dry Heat, Liquids, and Novel Processes.

Analytical Methods

  • Chemistry and Microbiology – method validation, verification and confirmation
  • USP and customized methodologies, stability methods
  • Method Transfers