Research & Development FAQs
Please find below a collection of FAQs regarding the logistical requirements surrounding R&D, including best practice for using dry ice shipping solutions and how to apply for shipping licences.
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Dry ice is available in solid blocks or as individual pellets of a few centimetres length. Pellet dry ice is most convenient for assembling dry ice shipping systems as it is easy to pour and naturally fills available space. Dry ice block would need to be prepared to the correct size to fit.
A dry ice shipping system for moving frozen product starts with an insulated box. The product being shipped is normally loaded into the box first. A temperature monitor may also be included and should be started at the correct time.
Now the dry ice needs to be loaded. Caution must be exercised when handling dry ice and all relevant Health & Safety procedures must be followed. Dry ice is very cold (around -80°C) so there is a risk of cold burns. It also gives off gaseous carbon dioxide – an asphyxiant – so must only be stored and used in appropriately ventilated and supervised areas.
Dry ice pellets are usually simply poured on top of the product and temperature monitor. Guidance from the packaging manufacturer will determine how much dry ice is to be added. The shipping system should have been correctly validated to meet pharmaceutical documentation needs.
Pellets usually come in 10kg bags – it’s worth bearing in mind that these bags will likely have a little more than 10kg in them when they arrive from the supplier but will lose weight in storage over time as carbon dioxide gas is given off. Thus a bag of dry ice used several days after delivery could have significantly less than 10kg inside. Thus weights may need to be checked against the expected bag contents.
Once the desired quantity of dry ice has been loaded in the lid can be sealed. It’s important at this time to check pellets aren’t stuck in the seal of the lid – this could keep the lid ajar and allow a warm draft into the internal of the box.
The sealed dry ice system is now ready to go off into the specialist logistics network.
Yes some goods may require an export licence, such as CITES material, some pesticides and materials that are controlled under anti-terrorism and warfare laws. Biocair can advise you on export requirements.
We can advise you regarding different permits required. A change to the constituents of a nutrient broth could negate the need for a permit. It’s always wise to check first.
Biocair is a courier company, as such we do not require a licence to move controlled drugs. The shipper/consignee must apply for the licences to move the materials. Biocair will need to see a copy of this licence before the shipment can commence, as there may be certain conditions that concern transport.
Many EU countries have their own import requirements which sit alongside EU regulations. Some materials will require licences wherever they are sent. It is always wise to check with us.
As with any aspect of regulatory compliance, the license requirements will depend upon the following criteria:
Each of these aspects will affect which regulatory agencies are concerned with the consignment and consequently what licenses and/or documents will be required.
Biocair Note: Biocair offers specific regulatory advice dependant upon these details.
The application process for licenses will vary depending upon the country of origin and destination. Some regulatory agencies offer electronic submissions services, whereas others require hardcopy applications.
Biocair Note: Biocair can offer advice as to the application process dependant upon the specific licenses required.
In brief, the following information should always be supplied to ensure that the applicable regulations can be provided:
Further required details will depend upon these factors.
Biocair Note: Biocair will use the provided information to identify the appropriate regulations prior to shipping. Specific information will be requested in compliance with the regulations.
An example of some of the types of regulation / standards applicable locally, nationally and internationally would be:
Regulations change for different countries, even different ports into the country. These import reglations can change monthly. For instance if a country has had an outbreak of “ foot and mouth” disease they will find it difficult to export products containing bovine material (even FCS or BSA) to countries where there is a thriving beef trade. It is always wise to check with the specialist courier first.