Packaging

Our Packaging & Handling

We use packaging components which permit easy and safe handling, while protecting the integrity of the products. Liquid products, including NMR Solvents, are sealed in ampoules or are packaged in screw-cap bottles, when appropriate. Multi-dose septum vials are used for selected products. Solids are generally packaged in screw-cap bottles.



Can CLEARSYNTH reference materials be re-used after the seal has been broken?

Unless otherwise stated our powder reference materials are not air or moisture sensitive. In such cases opening the vial will not alter the product and the associated assay value. However, we can only guarantee integrity of our reference materials until first opening of the vial or ampoule. It is the responsibility of the user to ensure integrity afterwards by correcting further storage and handling of the reference material.

This is set out in section 5.7.4. of ISO Guide 34, which specifies that;

'The reference material producer shall ensure that the integrity of each individual reference material unit is maintained until the seal has been broken or up to the point when presented for analysis. The producer cannot be held responsible for the material once the seal has been broken.'


Removal of CLEARSYNTH ampoules from packaging

It is difficult to find a happy medium between ensuring ampoules are packaged securely for transit, and enabling them to be easily removed from the packaging on receipt. Likewise this balance exists between ensuring the ampoules themselves are strong enough not to break unintentionally, yet easy and safe to open at the predetermined breaking point when required. To minimize risk of breaking open the ampoules prematurely whilst removing them from the packaging, we recommend sliding them out rather than using the top of the ampoule as an anchor point for removal. The latter approach puts stress on the neck of the ampoule thereby increasing risk of premature breakage. Alternatively pressing gently on the outside of the packaging at the body of the ampoule to dispense it in a tablet fashion, or using the label to pull it out, if exposed, also helps to prevent breakage.


Long term storage conditions

We recognize that fridge and freezer space in a laboratory is often at a premium and that there are logistical challenges associated with the storage location of reference materials. For this reason our certificates detail the minimum specified storage requirements and those under which real time stability testing is performed. Unless otherwise stated, storing reference materials in organic solvent at temperatures below those specified is not detrimental, and in many instances can improve long term stability. Products in aqueous solvent should not be stored at temperatures below 0┬░C unless explicitly stated.


How stable are my reference materials after opening?

Unfortunately we are unable to advise on expiry and retest dates of reference materials, or subsequent working solutions, after opening. It is the responsibility of the user to ensure the integrity of the material once the seal has been broken, as there are too many laboratory specific variables (usage pattern, container, storage conditions, volume, dilution, solvent/matrix etc).

This view point is reinforced by section 5.7.4. of ISO Guide 34 (General requirements for the competence of reference material producers), which specifies;

'The reference material producer shall ensure that the integrity of each individual reference material unit is maintained until the seal has been broken or up to the point when presented for analysis. The producer cannot be held responsible for the material once the seal has been broken.'

Ideally solutions should be used shortly after opening the ampoule to avoid concentration changes due to evaporation. Likewise, powders should not be stored for any length of time after opening, due to the risk of water absorption from atmospheric humidity.

There are a number of methods used by laboratories for assessing the integrity of a reference material after opening. The frequency or approach may alter depending on the drug and its properties.