Competencies

Qualification & validation

We are experts in qualification & validation in the biopharmaceutical industry. We have more that 30 years of experience in the pharmaceutical business.

We are trained in The SRV concept and used to qualifications documented on paper or in TIMS validation platform. We can participate as Engineering responsible (ER) or Operation responsible (OR) for production process / laboratory equipment or cleaning qualification and validation for the same processes.  

Examples we can help with:
  • Project planning & execution
  • Vendor / tender materials & specification
  • SQP: Review & supplier approval
  • DER: Design review, design planning & execution
  • DQ: Design qualification
  • Change control: CR cases, follow-up & closure
  • DRA: Risk assessments
  • PQMP / VPL
  • URS: User requirement specification
  • RTM: Requirement traceability matrix
  • FAT / SAT: Protocols, testing & reporting
  • IV / OV: Installation & operation qualification
  • SOP: Creation & staff training
  • PFV / PV: Process & cleaning validation planning and reporting
  • Deviations handling for processes, cleaning, or qualification

Environmental monitoring

We provide comprehensive support to ensure your pharmaceutical environments meet the highest standards. From planning and design guidance to ongoing monitoring and reporting, we help maintain compliance and optimal conditions throughout your production and laboratory areas. Our team ensures processes are well-documented, staff are properly trained, and all activities are executed with precision, so your operations run smoothly and safely.
Let us help you with:
  • Environmental planning
  • Environmental trending & reporting
  • URS: Clean room & LAF benches
  • Environmental support for process design 
  • SOP: Guidance, job instruction & training
  • Qualification: Preparations protocol report and testing

Supplier documentation

The documentation in the pharmaceutical bussines reqrie a complete package for fulfilling requriemts, testing documentation etc.

We can help you with the documentation package and let you focus on you, delivering your product in the best quality at the specified deadline. We can help you with the documentation package

Examples we can help with:
  • SQP Supplier quality plan
  • RTM: Requirement traceability matrix
  • Vendor documentation package
  • Preparation, test and reporting: FAT, SAT, IV protocols and reports
  • User manuals for process equipment

Single-use bioprocessing (SUB)

We are experienced in designing, qualify and validate single use equipment for the pharmaceutical industry. We have experience from single use Bioreactors, mixing systems and filter systems. plastic-based equipment (like bags, tubing, connectors, filters, peristaltic pumps) for one-time use in biopharmaceutical manufacturing.

The SUB systems replace traditional stainless-steel systems to increase flexibility, reduce contamination risks, lower production costs (by eliminating cleaning/validation), and speed up batch changes in both upstream (cell culture) and downstream (purification) stages. SUBs systems are a fast oputunity enable faster product development and more dynamic manufacturing for pharmaceuticals and other industries. 

Let us help you with:
  • URS: User specification
  • Risk assessment
  • Tender material
  • Implementation
  • DER: Design review, design planning & execution

Cleaning qualification & validation

Cleanning is a major part of all pharmaceutical production and laboratory processes. EngFLEX has the trained competences and experiences for defining and helping with cleaning of all process systems and products.

EngFLEX is experienced in cleaning qualification and validation of batch to batch and product change over.

For processes like:
  • Utility and solvents
  • Fermentation (Media and delivery systems)
  • Recovery down stream processes
  • API drying systems and processes
  • Purification (upstream processes), modifications, columns and packaging systems
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