Validation Services for Biopharmaceutical Industry – Confidence®

Validation Services for the Biopharmaceutical Industry

Ensuring Compliance, Elevating Confidence

For over 25 years, GreenBiotec has been a trusted partner in validation services for the biopharmaceutical industry. We bring a deep understanding of regulatory requirements, ensuring compliance and safety throughout your product lifecycle. Our consultative approach addresses your validation challenges, offering swift, tailored solutions that meet the most rigorous industry standards.

Why Choose Green Biotec?

1. Rapid Validation Turnaround
We deliver validation studies in as fast as 6 weeks, minimizing project delays and ensuring timely market release.

2. Unique Expertise in Extractables & Leachables (E&L)
With our unparalleled expertise, we leave no unknowns or open questions, providing comprehensive safety evaluations for all Green Biotec products.

3. Cost-Effective, Risk-Based Approach
Our tailored risk-based methodologies ensure cost efficiency while maintaining regulatory compliance.

Comprehensive Validation Solutions for Biopharmaceutical Processes

GreenBiotec Confidence® offers a full range of validation services across various processes, ensuring regulatory safety and process integrity for single-use systems (SUS) and conventional equipment. Our services cover key bioprocess components, including bags, sterile filters, virus filters, and more.

1. Buffer & Media Preparation
  Precise formulation and preparation of buffers and media ensure the success of your bioprocesses.
2. Fermentation
  Optimize microbial growth and yield with expert fermentation services.
3. Purification
  Elevate product purity with specialized purification processes.
4. Concentration & Buffer Exchange
  Streamline production with efficient concentration and buffer exchange services.
5. Sterile Filtration
  Maintain sterility and product integrity with our filtration services.
6. Storage
  Secure your products with our reliable storage solutions, preserving potency and stability.
7. Final Filling
  Ensure aseptic and precise final packaging, ready for market release.

Virus Clearance Services

GreenBiotec Confidence® ensures thorough virus clearance with fast turnaround times. Our services include feasibility studies, process design, optimization, and GLP virus clearance studies.

1. Feasibility Studies
  Assess the viability of your project with comprehensive feasibility evaluations.
2. Process Design & Optimization
  Enhance process efficiency with Design of Experiments (DoE) methodologies.
3. GLP Virus Clearance Studies
  Ensure compliance with regulatory standards through rigorous viral clearance validation.

Extractables & Leachables (E&L) Testing

With our E&L expertise, we provide detailed assessments and testing for Green Biotec products to ensure product safety and regulatory compliance:

1. Extractables Assessment
  Identify potential extractables in your materials for a thorough safety analysis.
2. Extractables Study
  Understand material interactions through in-depth extractables testing.
3. E&L Storage Study
  Assess the effects of storage on material safety and quality over time.
4. Leachables Testing
  Ensure safety by detecting and quantifying leachables in your products.
5. Safety Evaluation
  Holistic safety evaluations ensure regulatory compliance and consumer well-being.

Sterile Filtration & Single-Use System Validation

Our validation experts identify and validate microbiological and physicochemical aspects for filters and single-use systems. We provide comprehensive testing, including shipping and storage validation, to maintain product integrity across the logistics chain.

1. Microbiological Studies
  Safeguard your products with microbiological testing to meet industry standards.
2. Physico-Chemical Studies
  Gain insights into the material properties crucial for product performance.
3. Shipping & Storage Validation
  Ensure your products remain intact and effective during transportation and storage.

Particle Validation & Inspection Standards

We offer certified visual inspection training programs and defect test kits to ensure your products are “practically free” of particles, enhancing quality control and product safety.

1. Loose Particles
  Identify and mitigate the risks posed by loose particles.
2. Defect Test Kits
  Enhance quality assurance with efficient tools for identifying defects in your products.

Conclusion

Green Biotec’s Confidence® Validation Services ensures compliance, operational excellence, and cost-effective solutions for the biopharmaceutical industry. With our expertise, swift turnaround, and commitment to regulatory safety, we are your reliable partner for validation services from start to finish.