Servicio de validación para respaldar la seguridad del proceso
Proteja su producto medicinal contra la contaminación
Requisitos legales, aceleración del tiempo de comercialización, alta eficiencia en los costos: Comprendemos los desafíos diarios de la industria biofarmacéutica y sabemos la importancia que tiene en su negocio. Con el Servicio de validación de Sartorius, completamos la validación de su proceso.
Compliance with All Regulatory Requirements
In a GMP-regulated environment, you as a manufacturer are required to monitor factors influencing the production of medicinal products. Possible contaminants such as bacteria, toxic substances or particles should be evaluated. This is precisely where the Sartorius Validation Service comes in: Our specialists are well trained in test procedures that meet all regulatory requirements and quality standards.
Our service includes microbiological and physicochemical tests as well as extractables | leachables.
Validation Services Covers Numerous Process Components
Whether you’re implementing single-use systems for your fluid management or whether your production process involves conventional equipment made of stainless steel, our service includes tests for process components such as:
- Filter elements
- Disposable containers and bag systems for fluid management
- Bags for freezing and thawing processes
- Mixing systems
- Disposable bioreactors
- Transfer systems
- Hose systems | connectors | seals
- Complex single-use systems and processes
Our Approach: Individualized Consultation, Customized Test Coverage
Sartorius develops and implements the optimum test coverage for you — based on a risk-based approach for process validations and adapted to your specific production environment. Our experts provide you with scientifically sound and practical recommendations and we always take your special requests into consideration, which is why we pride ourselves on a customized and focused approach. By furnishing you with test coverage based primarily on all of your critical production steps, we guarantee the highest process reliability and rapid time-to-market.
Why Process Validation with Sartorius?
Minimize all risk factors and take advantage of high process and medicinal product safety. Sartorius specialists have outstanding expertise in the fields of microbiology, physics, chemistry and extractables | leachables.
- One-stop service: We take care of the overall project management
- Sartorius combines regulatory, analytical and process-specific knowledge in a single team
- Risk-based approach for efficient testing and rapid time-to-market
- Global presence and short delivery times
- Modern, state-of-the-art laboratories
- More than 20 years of experience with polymer and elastomer leachables and extractables
Extractables | Leachables: Tests for Polymer-based Process Components
As a manufacturer, you must ensure that a comprehensive extractables and leachables analysis (E&L) is performed. Only then will your pharmaceutical product be able to pass regulatory review. Sartorius has created extensive extractables guides for the different single use components that we manufacture. These guides form an important basis in the context of process validation and are readily available to all of our customers. However, the final step in process safety is the complete validation of the individual component with the individual contact fluid. Our experts support you in handling this task: Thanks to years of experience, we can draw on a full gamut of techniques that are cutting edge in the industry. In conjunction we also employ standard techniques such as HPLC-UV, GC-MS, HS-GC/MS, LC-MS, LC-MS-MS, FTIR, ICP-MS, ICP-OES, NVR and TOC.