The Sartorius Cubis balance together with the Pipette Tracker Software was installed by Labotec at the South African National Control Laboratory for Biological Products (NCL) at the University of the Free State. The aim of the new system is to make the performance of calibration-checks of pipettes more manageable and minimize paperwork. The NCL performs testing, evaluation and release of all batches of vaccines for human use in South Africa, and is the only vaccine testing laboratory of the Medicines Control Council in the country accredited to do vaccine testing for the World Health Organization.
The NCL ensures that South Africa receives high quality and safe vaccines, making it imperative that pipettes used in the process are repetitive and accurate. Marlena Visagie, QA Manager at NCL explains, “The new Cubis balance and Pipette tracker software system calibrates pipettes used for vaccine testing. At the NCL we have about 50 pipettes to perform calibration-checks on. This is performed on a 6 monthly basis. The calibration –check system currently in-use was time consuming; the process was manual and accompanied by a lot of paperwork”. She added that, “this system will allow us to perform pipetting repetitions faster and generate electronic reports automatically. It also will allow for a quality assurance trail that is stored electronically”.
Sartorius Cubis balances are designed for individual integration into a specific application, and together with the Tracker Software the system is able to schedule calibrations, automate data collections during calibration, perform all calculations and corrections as well as produce reports. It is suitable for single and multi-channel pipettes and liquid dispensers of fixed or variable volume, volumetric glassware and other devices that require calibration checks on a regular basis. In fact this very feature and its suitability for such a wide range of dispensers was an important consideration for NCL. “The pipette Tracker Software has a selection of 1100 pipettes to choose from, commented Marlena Visagie. In addition, she added that, “data can be transferred via interface to a computer and reports can be generated immediately. The Cubis MSU225S – 100DU model the NCL chose to use allows automatic levelling and environmental self-adjustments”. The Cubis system meets GLP and ISO requirements and will enable any company to meet their accreditation requirements, and at the same time allow for custom protocols based on internal SOPs to be configured, saved and used at run-time. To ensure that the staff at NCL are well equipped to manage the system, Labotec provided on-site training.
The NCL was established in 1998 at the University of the Free State through a tender from the National Department of Health. It functions as the Biological test laboratory of the Medicines Control Council. The mission of the NCL is to ensure that all human vaccines used in the country are safe, efficacious and of a high standard. Biological products are different from pharmaceutical products, in that the raw materials used in the manufacturing of the vaccine have inherent built-in variability. Each lot of vaccine manufactured is subjected to quality control. This ensures the vaccines are manufactured according to the required pre-requisites and specifications of registration before it can be placed on the market, and a release certificate issued for use.