Biobanking: from in-house activity towards high-end specialty service
In recent years, biobanking has evolved from an in-house process towards an outsourced speciality service. This evolvement has been made possible by the intensive utilisation of technology and dedicated knowhow to store and distribute biological specimens in a fully GMP compliant process and infrastructure. These facilities are organized to deal with human biological specimens from a large number of people. Multi-centre medical studies based on human samples are increasing and have become of major importance for future patient care. The future of bioprocessing demands flexible and scalable cleanroom solutions that can accommodate the rapidly evolving landscape of biopharmaceutical products while also minimizing the impact on the environment.
The scope of biobanking activities –acquisition, preparation, maintenance and provision of biological materials, and their validation– is compatible with the structure of ISO17025. This standard states that biobanking activities need to take place in cleanroom environments that are validated at all times. This means that cleaning of organism containment areas should be performed by authorized and trained staff. Monitoring systems, including equipment monitoring and alarm systems are established to monitor both locally and remotely, with plans to respond and notify at any time in case temperature ranges are exceeded. The function and temperature of each biobanking storage unit should be checked and recorded continuously. All storage units are therefore provided with a temperature monitoring system that can be read and of which the data can be exported. Alarm conditions allow an immediate response time to ensure that no damage to the stored materials occurs.
How pre-engineered cleanroom solutions guarantee a flawless start-up and integration
Design for quality assurance and design for risk mitigation are inevitable steps to take in the design of any cleanroom facility. During the design phase of an ABN Cleanroom Technology pre-engineered solution, we have taken the most standard User Requirement Specification (URS) into consideration.
A URS brings together system requirements from multidisciplinary sources to support system design, commissioning & qualification (C&Q), operations and maintenance. Within the commissioning and qualification process, it is a fundamental document that identifies the product and process requirements for the system.
User requirements related to product quality are based on product knowledge (CQAs), process knowledge, regulatory requirements and site quality requirements. The product and process requirements in the URS serve as input for the commissioning & qualification process.
Quality risk management supports a scientific and practical approach to decision-making. Traditionally, risks to quality have been assessed and managed in a variety of informal ways. Well-known risk management tools are e.g. Fault Tree Analysis (FTA), Failure Mode Effect Analysis (FMEA), Failure Mode Effect and Criticality Analysis (FMECA). The importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance.
Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle. A model for quality risk management is outlined in the diagram (Figure 1).
The ABN Cleanroom Technology engineering team is able to provide dedicated support in compiling a URS document for various cleanroom applications. Reference to various successful experiences, the definition of the URS is created in a co-created form by bringing together the process knowledge of the client and the cleanroom design, build, commission and maintain experience of the ABN engineering team.
The URS and the successful compiling of the quality risk management assessment forms the foundation of the Basis of Design (BoD) and becomes the reference document to establish an integrated system that is suitable for the intended purpose. ABN Cleanroom Technology assists in setting up the URS in function of the entire lifecycle of the cleanroom system – from the design, commissioning, validation, operational utilisation until and including the expansion, upgrade or decommissioning of the cleanroom facility.
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As being an innovative leader in our market, ABN is providing pre-engineered cleanroom facilities as an all-inclusive as-a-Service offering that is fully compliant with the ISO17025 standards and related requirements like traceability, quality assurance and availability. This is guaranteed as each facility is equipped with a fully autonomous automated control system and remotely monitored via the GMP certified CleanConnect system. This enables end-users to solely finance a fully compliant facility per operational utilization with a guaranteed level of operational availability and condition traceability.
As end-to-end cleanroom solution provider, ABN Cleanroom Technology wants to take full responsibility to maintain, repair, reuse and upgrade the provided resources who provide contained air quality.
The ABN Cleanroom Technology cleanroom portfolio, ranging from indoor to outdoor cleanroom facilities, has evolved over time with Design for Sustainability and Design for Circularity as ultimate value proposition. The focal point has diverted from design and deployment of a cleanroom towards the design of a cleanroom that is maintainable and upgradable over time. However, only by transforming the business model towards an as-a-Service exchange of capital, we are able to take our responsibility to sustain the delivery of value throughout the entire lifecycle of the facility via condition based maintenance and the deployment of suitable functional upgrades.