Articles & News
Have You Scheduled the Servicing & Maintenance For Your Equipment Yet?
Scheduled servicing and maintenance ensures the efficient running and life span of your equipment.
The ability to operate specialised laboratory, pilot, and production scale equipment to ensure specific R&D, or manufacturing throughput projections are consistently met in a timely manner, is more important than ever in our technology driven environment.
Whether a start-up, multinational company or an academic institution, users rely on the efficient day to day running of their systems. ‘Downtime’ is certainly a word that companies would wish to avoid.
As a result, markets have seen an increase in rigorous qualification testing procedures in conjunction with ever-improving industry standards to ensure materials of construction and process parameters are suitable for environment and the stress equipment is placed under.
The Service Department of Biopharma, based in the UK, recognise these stringent requirements, and, via our dedicated technical engineers, with more than 50 years combined experience, Biopharma offer customer assistance in all aspects of machine qualifications, whether your equipment be a large scale freeze dryer, centrifugal evaporator, or high pressure homogeniser. These include the following:
- Site Acceptance Test –SAT–
- Instrument Qualification/Operational Qualification – this could include a full shelf mapping exercise, for example
- Calibration routines across multiple sensors, such as temperature/vacuum gauges
However, due to raised demands in certain product areas, full qualification of equipment is in many cases, no longer enough to guarantee usage of the instrument for the next decade and beyond.
The need to partake in regular servicing to help protect and maintain your original investment has become more prevalent, to satisfy audits from governing bodies like the FDA, or MHRA. In light of this, Biopharma service engineers are able to visit customer sites to re-validate tests on a periodic basis e.g. 3, 6, or 12 monthly; normally for shelf mapping and sterilisation mapping cycles, but these visits could be scheduled to incorporate any part of the original qualification testing.
Biopharma is registered and certified with REFCOM and holds a current company certificate number REF1006384. Under EC regulations, we are permitted to handle refrigerants and maintain all types of refrigeration systems; done so through our fully qualified and certified –in accordance with F Gas and ODS Regulations: Category 1–, engineers.
All calibration instruments have been specifically selected, and certified to UKAS traceable standards. Copies of the calibration certificates accompany all reports where calibration has been part of the service, to allow for traceability.
To support our operations, practices, and procedures, Biopharma also have full written documentation, method statements, SOPs and risk assessments, to confirm with our quality management systems, which are accredited BS EN ISO 9001:2008.
Our overall aim is to provide a partnership in expertise, technical support and resources with the client, to ensure systems maintain operation at highest standard, thus providing a high degree of confidence in its continued operation, performance and reliability.
To discover more about how the Servicing & Maintenance Department can help you, please contact Kevin Smith (Technical Director) for more information.