Kbiotechoffers a complete range of services to meet customer’s targets
Services and Maintenance
We offer a complete range of services and maintenance solutions to meet our customers’ requirements.
Aftersales service and technical assistance for bioprocess equipment
KBiotech Quality Assurance System ensures accurate technical assistance for bioprocess equipment, supervised by our general management and based on the TÜV-certified, ISO 9001 reference system, it applies across the entire organisation and covers all the company’s activities in the following fields:
- Invitations to tender
- Customer orders
- Evaluation of suppliers and subcontractors
- Orders placed with suppliers and subcontractors
- Preparation, production start-up
- Inspection, tests, metrology
- Document management and storage
- Product follow-up: After Sales Service
- Disposition of non-conformities: preventive and corrective action
- Personnel training in Quality matters
- Internal operating audits
Our professional approach goes hand-in-hand with service and maintenance guidance to ensure our customers receive a rapid response in terms of technical assistance for bioprocess equipment and spare parts availability.
Support service and worldwide technical assistance for bioprocess equipment
KBiotech has been developing and extending the role of its aftersales department, and service support in particular. Alongside the support available from our headquarters, we have also developed additional, high-quality service and support structures throughout the world.
KBiotech has a worldwide network of subsidiaries, representatives and trained aftersales mechanical and electrical systems specialists, and our partners regularly deliver dedicated, in-house training courses to ensure their engineers’ skills are appropriate and up-to-date.
All of our local service engineers are fully certified through practical assessments of their abilities and the knowledge gained from in-house courses.
Prompt sourcing of parts for bioprocess equipment to function correctly
Local stocks of spares and consumables, together with a rapid, 24-hour technical data source, are also critical to our success. Our colleagues worldwide take their responsibilities very seriously and provide a high level of local technical assistance for bioprocess equipment, covering service, peripherals, and upgrades.
KBiotech is committed to ensuring high levels of efficiency and quality in its services. Our challenge is to ensure the right personnel and parts are available to our customers when required and, naturally, this depends on the right skillsets being available in the right geographic location. Our well-established ability to customise installation and testing work to meet specific user requirements is another factor in providing efficient, effective service to our customers.
Quality and Validation
Operational qualifications for bioreactor validation
Kbiotech has integrated operational qualifications to meet highly demanding technical requirements governing the design, inspection and validation of bioreactors and bioprocess equipment. They have been extended to include equipment qualification protocols, both for preliminary tests conducted in the workshop and for on-site pre-production testing.
Additionally, total control over product traceability enables identification of components, subassemblies, materials, and aftersales supplies as well as identifying the origin and characteristics of raw materials used in manufacturing.
Validation of bioreactors and bioprocess equipment
Kbiotech aims to support the validation process in the following areas:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Performance Qualification (PQ)
Qualification tests ensuring high-quality bioprocess equipment
All installation and operational qualification tests are performed following highly precise instructions that specify both the method and the applicable acceptance criteria. These instructions are validated and regularly updated within the Kbiotech Quality Assurance System. In addition, they are accessible to users, who are provided with full knowledge of the conditions under which this system has been tested.
Performance qualification tests are documented in special procedures prepared by Kbiotech in agreement with the user. This condition allows to work out a precise definition of the methodology in accordance with the process for which the installation has been designed.
Installation Qualification testing (IQ)
This testing involves verifying systems and subsystems, as well as collecting documents to show that installation characteristics comply with predefined specifications and regulatory requirements. A Construction and Inspection File is set up from the commencement of initial manufacturing operations and follows the product until the end of its process, with final inspection taking place before the product is released for initial qualification testing. This testing, which is conducted by qualified Kbiotech technicians, enables the implementation of automated process control and the verification of the hydraulic, pneumatic and electrical characteristics of the various components in the system.
Operational Qualification testing (OQ)
This testing verifies the proper operating condition of the systems and subsystems and that they work within the ranges and tolerances stipulated in the statement of work and defined specifications. These qualification tests are conducted by specialist Kbiotech technicians and, following installation of the equipment, enable the proper operation of all system elements and automated process controls to be verified.
Performance Qualification testing (PQ)
These dynamic tests verify the system’s overall ability to accomplish the process in a reproducible way while maintaining all critical parameters within their tolerance range. Kbiotech provides the necessary technical support to carry out on-site dummy runs (replacing the product with a placebo), until the specified performance levels are achieved and it has been verified that the results are reproducible.
The protocol, adapted to the requirements of each product, is documented in a specific procedure that is jointly prepared and accepted by Kbiotech and the client.
Traceability through cutting-edge codification techniques
Traceability applies to the construction of vats, assemblies, and their environment when subject to rules governing construction, use, and inspection or any other specific requirements. Kbiotech maintains complete control over its codification methods, enabling rapid tracing and location of all items used in its systems.
Faster traceability through an innovative Identification Code
The identification code pertains to all components and accessories received by Kbiotech, as well as subassemblies manufactured for the warehouse stores and all project-related design data.
Thorough Technical Documentation with Each Installation
Renowned for its high-quality autoclavable bioreactors, fermenters and gas analysers, Kbiotech considers technical documentation for bioprocess equipment as an essential factor in its approach to validation due to the need for careful documentation of every demonstration. Kbiotech delivers complete, “as built” documentation with every installation, including all modifications that may occur after delivery to site. These modifications are subject to additional clauses for all relevant documents and are listed chronologically.
What does the technical documentation for bioprocess equipment include?
Kbiotech documentation consists of main 4 files:
- Construction and inspection
- Qualification (IQ, OQ, PQ)
- Preventive and routine maintenance
Kbiotech and its partners work to industrialise your new processes achieve compliance with the latest applicable standards worldwide, such as BPF, GMP, and GAMP.
As an international company operating worldwide, Kbiotech provides multilingual technical documentation, including user and maintenance manuals available in English, German, French and Italian. Chinese, Russian and Japanese are available on request.
Please contact us for more detailed information!