Analytical instrument and software combination delivers excellence
Easy, compliant, accurate and efficient work results from a symbiosis of the UV7, a spectrophotometer from Mettler Toledo, and its LabX software. Dr Russell Kinghorn and his team benefit from this during their GMP laboratory work at Pharmalytics, Australia.
Life as the head of a GMP laboratory for the pharma industry can be easy. If all used instruments and processes are compliant with the regulations of a pharmacopeia or authority such as the FDA. This is the case with Dr Kinghor’s Pharmalytics, a GMP contract testing laboratory for pharma and related industries. His UV7, the other analytical instruments from Mettler Toledo and LabX PC software meet the regulations. This allows Pharmalytics to work virtually paperless.
As a result, the work of the team is further accelerated to become even more efficient. Pharmalytics has very few staff doing the work of 30, because they are not held back by paperwork. They do not have to worry about compliance because everything they do involving an analytical instrument already adheres to regulations. Due to the software, they do not have to witness each other’s results. Their results are absolutely traceable.
The following example out of Kinghorn’s practice shows the outcome of combining LabX and the UV7: a protein content assay was required from Pharmalytics. Kinghorn had never performed this specific analysis before: “I found a [pre-programmed] protein method in LabX. Imported it. Changed the name. Changed the calculation slightly to what I needed it to do. Saved it. Validated it. It was done. It ran a project for three weeks for a clinical trial into human patients.” The UV7 assay was validated to ICH guidelines, the worldwide standard for analytical method validation for pharmaceuticals.
Small, compliant, accurate instruments
Like all laboratory teams, Kinghorn needs reliable analytical instruments to successfully do the work. This is why he Russell Kinghorn chose the UV7 for his paperless lab. One of the biggest advantages is its small size. The UV7 will practically fit on a piece of writing paper to save expensive laboratory bench space. This is even the case if accessories are used. They are securely mounted on top. This means that the bench space can be used otherwise.
Kinghorn says that the UV7, “is a very good piece of equipment”. It complies, for example with the US- and EU-pharmacopeia. And in combination with the LabX, it satisfies the US and EU requirements for electronic data integrity.
Within a second, the instrument delivers the results of its analysis. It can do that because it works with a xenon flash lamp. Due to technological reasons, there is no warm-up required. Therefore, it is irrelevant whether the device is turned off or left on. Additionally, its users will not have to change the lamp because both lamp and UV7 have an estimated working life of 10 years.
Another feature supporting the work of Kinghorn and his team is the open sample area. The accessibility of the optical bridge containing the sample area is very beneficial. With regards both to measurement time as well as from a security perspective. Cuvettes are mounted and changed quickly. There is also no need to hide the sample area from ambient-light irradiation. It does not influence measurement integrity at all.
Kinghorn describes the LabX software as being “compliant, flexible, powerful”. The software itself complies with the same FDA regulations as any of the analytical Mettler Toledo instruments connected to it. In Pharmalytics these are for example the spectrophotometers, titrators, or analytical balances. All Mettler Toledo analytical instruments can be connected. Therefore, just one interface to other laboratory networks exists. This means: just one platform to train staff on. And just one interface to other networks to service.
The FDA regulations specify that a second person is required to overview most actions being performed. In this case, LabX takes on this role and tracks every action of the instrument when it is in compliant mode. Therefore, no second person needs to review the analysis.
The software allows compliant, accurate, and fast work on each connected instrument. Kinghorn states: “The beauty of Mettler Toledo equipment is that the instructions come up both on the instrument’s terminal and the computer screen. Where possible, we have also minimised SOPs due to this feature.” All it needs is a detailed set up for the individual situation of the connected laboratory. This may be discouraging at times, but the results are worth it. Kinghorn describes his experiences, saying that LabX, “has its limits and it requires some effort to set up. But once it works it is perfect.” He adds: “What we have got LabX doing would make your head spin. It’s really cool!”
Validation made easy
The UV7 is a pharmacopeia-compliant instrument. Thus, it needs to be qualified at least annually. With CertiRef it takes just one and a half hours to qualify the optical measurement performance of the instrument. Kinghorn describes the process: “Just mount the CertiRef on top of the instrument. Plug it in. Log into the software and let it do its job.” He still remembers the time when it took one day to make up all the required solutions. No errors were allowed, otherwise, a costly ‘warning letter’ was issued.
When qualified analytical instruments and software are combined, the results will be accurate and repeatable in any case. As every step adheres to the regulations, the entire process is compliant.
Kinghorn can only run a paperless laboratory because he combined and connected outstanding developments. A precise UV7, qualified easily by the CertiRef and connected to other accurate analytical instruments via LabX will deliver integer data.