Modular sterilization and microbiological monitoring services from Früh Verpackungstechnik.
Specialized sterilization expertise available as needed. Ensure your processes comply with regulations, compensate for resource shortages in a targeted manner, and safeguard your operational flexibility.
Früh Verpackungstechnik is your partner for modular sterilization and microbiological monitoring services – individually combinable and tailored precisely to your requirements.
Why we offer this service
The requirements associated with sterilization-related processes and microbiological monitoring are continually increasing. At the same time, there is a growing demand for qualified resources. In order to strategically confront this trend, FRÜH Verpackungstechnik has established a modular service offering that can be combined as needed and provides support precisely in areas where additional expertise and capacity are needed.
How we support you
Evaluation of the correct sterilization procedure as a sound basis for further process design. Structured project planning with clearly defined timelines and milestones creates transparency when it comes to required quantities, process steps, and time windows.
Planning and completion of dose mappings, dose audits, and sterilization validations including inspection- and audit-ready documentation that complies with the relevant standards.
Supporting revalidations with the goal of optimizing loading concepts, designing processes more efficiently, and increasing process efficiency and product profitability over the long term.
Our services at a glance
1) Microbiological monitoring and endotoxin testing
Development and establishment of a resilient microbiological control system, from data collection to analysis:
- Bioburden determination and trend analyses
- Identification of microorganisms
- Support with deviation management (excursions)
- Support with microbiological risk analyses
2) Validation and regulatory support for sterilization
- Inspection- and audit-ready documentation that complies with the relevant standards and structured validation strategies: Completely implementation-ready validation packages, requalifications, and change impact assessments?
- Standardized reporting formats, technical support with audits, and inspections by the authorities
3) Sterilization consulting and execution support
- Method-specific support with a focus on process reliability and logging:
Validation of radiation sterilization processes (gamma and x-ray) - Dosage determination and routine dose audits
- Validation support for steam and EtO sterilization
- Product packaging service under clean room conditions (ISO 7)
Norms and standards
Our support is aligned with EN 556-1:
- EN ISO 11137 (radiation)
- EN ISO 17665 (steam)
- EN ISO 11135 (EtO)
- ISO 11737- 1 (bioburden)
- ISO 11737-2 (sterility inspections)
- ISO 11737-3 (endotoxin)
Why you should choose FRÜH
- Proven expertise in radiation sterilization and microbiological control
- Established, certified partner network
- Structured documentation for supporting regulatory submissions
- Experience with supporting audits and inspections
Ordering and contact person
For new and repeat service orders, from now on please use our new order form in the download area below.
The PDF form replaces the previous Word document that was sent out.
For specific, technical queries and coordination of the right procedure for you, our sterilization experts Alexander Müller and Nicole Buchberger are your direct contacts.
You can find all the details in one place here Serviceflyer Sterilization.
