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Klarwin pharmaceutical consulting and training services team

Pharma Technology Services

PHARMA TECHNOLOGY

A project’s long-term success depends on the quality of services behind the equipment. Klarwin provides a complete service ecosystem — from installation and validation to preventive maintenance and permanent technical support — ensuring optimal performance throughout the entire lifecycle.

  • Multidisciplinary teams specialized in sterile processes, pharmaceutical utilities and single-use technologies
  • National service network with mobile teams for rapid intervention
  • Full GMP compliance on all interventions, with audit-ready documentation

Specialized Training

Equipment reaches its full potential only when operated correctly. Klarwin delivers training adapted to each solution — on-site at client facilities, in our specialized centers, or online.

Programs cover: equipment operation and advanced settings, preventive maintenance, safety procedures, cleaning best practices and standardized technical documentation.

GMP validation training session for pharmaceutical production teams

GMP and Validation Training

GMP compliance and correct process validation are fundamental to delivering quality medicines and meeting regulatory authority requirements. Klarwin delivers specialized sessions designed to translate theoretical concepts into applicable competencies:

GMP fundamentals, applicable/customized standards and legislation
Validation types: equipment, processes
IQ/OQ/PQ qualifications — validation procedures and tests
Personnel and process documentation preparation for audits and inspections
Real-world case studies with demonstrated solutions

Consulting, Scale-Up Testing and Sterile Filtration Validation

Scaling from laboratory scale to pilot scale and then to industrial production involves significant technical challenges — particularly in sterile filtration. Klarwin provides complete support for a risk-free transition:

Technology evaluation and optimal filtration strategy selection
Pilot-scale testing for determining the values of critical process parameters
Controlled scale-up with equipment and production flow adaptation
Sterile filtration validation per EMA, FDA, EP and GMP requirements
Complete audit documentation — test reports, validation reports, full process traceability
Pharmaceutical consulting — sterile filtration validation and scale-up testing

Integrity Tester Calibration

Integrity testers are essential for monitoring filter performance in biopharmaceutical processes and water for injection. Klarwin provides integrity tester calibration service per manufacturer specifications, with metrological traceability to international standards:

Functional and complete verification of all measured parameters
Calibration with internationally certified reference equipment
Calibration certificate with full traceability, compliant with GMP and ISO 17025
Preventive and corrective service for keeping the equipment in optimal operating condition

From training to calibration — Klarwin Pharma services

Specialized training, GMP and validation programmes, consultancy for sterile filtration and scale-up, and integrity tester calibration with full metrological traceability. Klarwin supports your team across every stage of pharmaceutical operations.

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