UV7+LabX: Easy and efficient compliance

Easy, compliant, accurate, and efficient work results from a symbiosis of the UV7, a spectrophotometer from METTLER TOLEDO, and their 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 like the FDA. This is the case with Dr. Russell 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 thirty, explains Dr. Russell Kinghorn. Because they are not held back by paperwork. They do not have to worry about compliance. Because everything they do involve 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 Dr. Russell 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 3 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.

UV7: Small, compliant, accurate, fast

Like all laboratory teams, Dr. Russell Kinghorn needs reliable analytical instruments to successfully do the work. One of those instruments is the UV7 from METTLER TOLEDO. This is why Dr. Russell Kinghorn chose it 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.

Dr. Russell Kinghorn declares 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 the UV7 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 Dr. Russell 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.

LabX: Compliant networking

Dr. Russell 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.

LabX allows compliant, accurate, and fast work on each connected instrument. Dr. Russell 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 minimized SOP’s 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. Russell describes his experiences: 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!” The example from the beginning shows how easy it works.

Validation made easy: CertiRef™

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 hour to qualify the optical measurement performance of the UV7. Dr. Russell 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. “CertiRef is ingenious!” praises Russell in the process. 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.

Outstanding results: Networking of the best

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.

Dr. Russell 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.

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