Containing success

The key to good research and development is reproducibility of results, but with the vast array of variables that challenge the modern scientist, any help is a welcome addition to the lab. Tim Schofield thinks he has the answer as he asks, are you using the right sample container?

The role that sample containers play in the field of research is changing. These days research laboratories, whether it be for clinical trials, QA/AC pharmaceuticals, drugs manufacturers, forensic research or environmental testing, are no longer looking for just a container. They are increasingly aware of the effect that the choice of container can have on their test results. To help them with the challenges they are facing, they are looking for companies who can also act as a technical support resource.

Research laboratories are facing the same challenges as other industries. They are required to increase their productivity and reduce their costs whilst maintaining the volume of tests and quality of the test results.

It is no longer satisfactory for a supplier to just provide a container - it is crucial to supply the right container for the right application. Laboratories are looking for suppliers who become true partners and who recognise the need for new and innovative solutions to meet the growing need for higher standards of purity. Laboratories not only require diversity of the products on offer but also flexibility with regard to the ordering process. And, above all, they are looking for expertise to help them with the sourcing of contaminant-free containers for their particular environment.

Each specific critical environment has its own particular requirements. In the past researchers took responsibility for the cleaning of their containers. In their fight to reduce the number of ‘faulty’ test results and to increase their efficiency, researchers realise container cleaning is one area they should be focussing on to achieve their goal. They are continuously on the look-out for ready-to-use, contaminant-free containers. However, there is not one container that suits every application. A container which is clean to one user may not be so to another. Clean is determined by the application, by the results that are expected.

It is crucial that container manufacturers and suppliers share the concerns of the researchers and recognise that laboratories need products and services that fully meet their requirements and expectations. It is vital that they are specialists and are capable of examining the application for which the container will be used. The answer may lie in either a ready-to-use, pre-cleaned container or in a custom cleaned container, and depends entirely on which cleaning process best suits a laboratory’s particular requirements.

There are a number of standard and custom processes as well as surface modification processes that can be used to ensure that the container supplied is the right one for a specific application and is ready-to-use.

This includes low particle cleaning, depyrogenation and chemical cleaning for trace analysis. 

• Particulate cleaning is recommended for numerous applications in the pharmaceutical, biotech, medical, semiconductor industries, and anywhere where clean rooms or controlled environments are utilised.
• Depyrogenation is particularly suited for use with injectable or parenteral drugs, lyophilisation, final packaging prior to drug delivery, stability studies and clinical trials.
• Chemical cleaning is based on the user’s choice of a combination of several different cleaning methods for removal of trace inorganic, trace organic, volatile organic or total organic residues.

This type of process is particularly suitable for use in biotech/pharmaceutical and analytical applications. It includes silanisation, siliconisation and silane treatment. 

• Silanised containers have been treated to neutralise active sites in glassware. The process allows materials to remain stable and prevents them from reacting with the glass surface. It also prevents the components of the glass from leaching into the sample.  Silanised containers are particularly suited for use with proteins, assays of blood serum and pharmacological examination and analysis of therapeutic drugs.

• Siliconised products are physically coated with a medical-grade silicone emulsion to prevent sample material from reacting with the glass. They can be used in the same applications as silanised containers.

• Silane treated containers are particularly useful in quantitative analysis or for the storing of materials. The silylating agent ties up the glass surface, thus making it less reactive.  Valuable personnel time is saved and waste costs are minimised.

Other cleaning requirements can be met through custom cleaning services. Table 1 is a brief overview of the kind of processes involved and the applications they serve.

Many laboratories are working with non-standard containers. What are the choices available to them? Should they change the tools they are using and the way in which they carry out their research? The answer is ‘no’. The same standard and custom processes, surface modification processes and custom cleaning processes can be applied to non-standard containers. The issues to consider here are whether the service includes the cleaning of closures or other component parts, flexibility (small or large quantities with scale-up planning), full customisation (cleaning, packaging and certification), the state of the cleanroom facilities, traceability, and the range of containers for which the service is offered.

Where the use of the right container offers a cost-effective solution to faulty test results and an increase in productivity, there are other areas that will offer you peace of mind and added value to our customers. It is advisable to investigate whether the containers are custody sealed - are they protected from contamination from start to finish? Does the supplier/manufacturer offer full traceability, including long term archival services? And finally, always remember to check that your containers come with a Certificate of Analysis.

So, the key things to remember when choosing containers:
• Work with a specialist partner.
• Only use products that meet your requirements.
• Explore the availability of flexible solutions.
• Remember the Certificate of Analysis, custody sealing and full traceability.

By Tim Schofield, director of Sheild-Scientific