PSI Validation & Consulting is highly knowledgeable in the latest cleaning validation techniques and methods thus providing our clients in the pharmaceutical, biotechnology, and life science sectors.

We provide the following specific cleaning validation services.

• Commissioning.
• IQ, OQ, PQ.
• Cleaning validation master plan.
• Authoring and reviewing validation protocols, including selection of worst case conditions, residue limits and sampling methods.
• Design manual cleaning regimen for specific cleaning needs.
• Revise existing cleaning validation programs to comply with FDA and cGMP requirements.  

For additional service requirements, please contact us to discuss your specific consulting needs with one of our company personnel.

Sterilization / Autoclave Validation

PSI Validation & Consulting is highly knowledgeable in the latest Sterilize In Place (SIP) methodologies involving process tanks, autoclaves and dry heat ovens.

We provide the following specific SIP services.

• Determine steam pressures, temperatures, routes, and durations for maximum steam penetration and cycle efficiency. Defining Biological Indicator locations for proper sterility assurance.  Review P&ID's. 
• Authoring and reviewing validation protocols, including selection of worst case conditions and sampling methods.
• Author validation master plans.

 For additional service requirements, please contact us to discuss your specific consulting needs with one of our personnel.

Process Validation

PSI Validation & Consulting prepares a plan of the validation study to ensure that the process is captured within the validation protocol.  Planning of process validation would include any relevant reports such as IQ, OQ, PQ of relevant equipment and additional documentation that would complement the final validation package. As part of process validation PSI would perform the following:

• Understand process parameters and process characteristics for control and monitoring methods.

 PSI Validation & Consulting will perform a thorough process validation including authoring protocols, revising or updating SOP's, authoring investigations, and preparing the final report and validation package.

 For additional service requirements, please contact us to discuss your specific consulting needs with one of our company personnel.

Computer Validation

PSI Validation & Consulting provides computer validation services using robust methodologies and covers hardware systems, software, change controls, data management, as well as evaluation of electronic records and signatures (CFR 21, Part 11).

For additional service requirements, please contact us to discuss your specific consulting needs with one of our company personnel.

Control Temperature Units and Temperature Mapping

Ensuring temperature control within defined bands and ensuring uniformity in the process.

PSI Validation & Consulting has extensive experience in providing control temperature unit validation support and temperature mapping for refrigerators, long-term storage freezers, and incubators with humidity and CO₂ control requirements. 

For additional service requirements, please contact us to discuss your specific consulting needs with one of our company personnel.

Process Investigations / Technical Writing

PSI Validation & Consulting has extensive expertise in providing solutions to reducing investigations by performing effective and extensive root cause analysis using lean six sigma techniques.  We also author investigations and determine appropriate CAPA's that mitigate adverse manufacturing events.

For additional service requirements, please contact us to discuss your specific consulting needs with one of our company personnel.

Quality Assurance

PSI Validation & Consulting can provide you with efficient and timely batch record review, validation protocol review, and SOP review to ensure that you are meeting cGMP standards and documentation requirements.

For additional service requirements, please contact us to discuss your specific consulting needs with one of our company personnel.

Quality Control

PSI Validation & Consulting has experts in cGLP, and the latest methods in designing testing methods for your intermediate or final product.  We can help with assay development, product characterization and other analytical and qualitative testing protocols. 

Cleanroom Design and Optimization

We will assess your operations and provide you with the most effective cleanroom structure to meet your objectives.

• Layout
• Material Flow
• HVAC
• Environmental Classification
• Airflow Visualization