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SEVEN STEPS TO SUCCESS IN CAPSULESIntroduction
1.
Packaging of Empty Capsules
2. Transportation of Empty
Capsules 3. Inspection of Capsules on
Receipt 6. Packaging of Filled
Capsules 7. Shipping of Filled Capsules
This technical note has been prepared to assist you in using
any size or brand of empty hard gelatin capsule. Empty Hard Gelatin Capsules are shipped with a moisture
content between 13-15%. It is important that this moisture content is maintained
and exposure to high temperatures or cycling between high/low temperatures is
avoided. When capsules are empty (unfilled) they are most susceptible
to damage as the capsule walls are unsupported and there is a tremendous volume
of air contained inside the capsule that can extract or release moisture from
the capsule walls. Once the capsule is filled the walls are supported and the
air inside the capsule is essentially eliminated. Thus, the sensitivity of
capsules to environmental conditions is reduced. The major cause of customer problems with capsules is improper conditions
during storage and filling or inadequate final packaging. Torpac is ready to
assist you in handling and packaging capsules. Please contact us. To protect empty hard gelatin capsules from exposure to large
variations in the surrounding relative humidity, they are packed in food grade
anti-static plastic bags inside heavy-duty corrugated cartons. Capsules
shipped by air from our factory are lined with insulating thermocool (styrofoam). Care must be taken during transportation to ensure no damage to capsules. 1. Do not leave shipments on a loading dock or in a truck. 2. Ensure your customs broker is aware that capsules are heat
sensitive and can arrange pre-clearance of the capsules through customs. Torpac
will fax the invoice and Airway Bill details directly to your customs broker
before the shipment is dispatched to assist you in obtaining pre-clearance. Inspect your shipment on arrival. The following are examples
of heat damage during transportation:
Contact Torpac immediately if you observe the above. Please note the batch, box and drum numbers on the outer case and, if available, purchase order number and date of receipt. 4. Warehousing/Storage:If the proper storage conditions are observed, empty hard gelatin capsules may be stored for several years. Storage conditions are given in the table below:
The effect of prolonged storage (over a few days) in areas outside the recommended conditions may cause the damage indicated in the table below:
The following equipment is available for monitoring temperature and humidity. It is available from Torpac direct or from Cole Parmer (Tel. 800 323 4340). Temperature/Humidity Digital Type Indicator (Cole Parmer Model G-37100-00) $75.00 Temperature/Humidity Chart Recorder (Cole Parmer Model G-08372-65 Fahrenheit model and G-08372-75 Centigrade model) $450.00 5. Capsule Filling:Optimum filling conditions are between 20-25 C (68-77F) and 45% to 55% Relative Humidity to maintain the moisture content of capsules between 13-15%. Capsules can be used outside these conditions but within the normal storage conditions provided only the minimum level of stock is kept open to the atmosphere (one bag) and for a maximum of 1-2 hours.
Contact Torpac for the loan of a temperature/humidity data logger. This instruments accurately records the temperature and humidity in your storage and filling areas every 15 minutes around the clock for up to 1 month. 6. Packaging of Filled Capsules:The key is to avoid moisture gain or loss during long term storage. We recommend plastic bottles with a screw cap, pails with a cover or blister clam-shells. Customers have successfully used plastic bottles from 1 quart (1 liter) to 1 gallon (4 liters) in size. Size the bottle so there isn’t excessive head space (free space above the capsules). One customer is successfully shipping capsules 1,000 per plastic bag surrounded by Styrofoam peanuts and the outer container is a cardboard drum. Another customer, packs capsules in 0.5mm thick zip lock plastic bags. We do not recommend thinner bags as they allow moisture to escape or enter quickly. Blister packing (heat sealing a plastic blister to a foil or paper backing) requires special care to make sure that the heat involved in sealing does not lower the capsule’s moisture content and subsequently cause brittleness and capsule breakage. Advise your supplier of blister material that you are packing gelatin capsules so that they do not use plastic resins that release monomers that slow the dissolution of capsules. We do not recommend the use of desiccants as they absorb available moisture and increase the chance for capsule breakage. A few customers who ship copper oxide in capsules (a dense metal) use a foam padding at the bottom and top of the bottle to prevent capsule breakage due to shock. This is not required for other products. For examples of the above packaging click on Finished Capsule Packaging Examples. 7. Shipping of Filled Capsules:Based on capsules that have been packed in one of the packages described above, outer packaging is usually a cardboard box. Typically, 6, 12 or 24 plastic bottles are placed in a corrugated case. Some customers use a top and bottom "slip sheet" or ½ inch cardboard sheet in the outer cardboard case to offer protection from shock in transit. Customers who use cardboard drums or plastic pails to pack capsules do not use further outer protection. Warning: conduct a ship test of your product before releasing it for commercial sale. At a minimum ship your capsules in final packaging via UPS (in USA) or truck (lorry) to a few friendly customers at locations far away. Ask them how your packaging arrived. Or, contact us at Torpac. United Parcel Service will conduct an evaluation of your package at their Danbury, CT facility. Contact your local UPS Account Representative to arrange this test. If you have any problem in arranging the test, please contact us and we will assist you. Note, UPS had advised us that the test results will not be used to accept or refuse your package. The package you give UPS will be subjected to vibration and drop tests. Additionally, the outer cardboard container will be evaluated for bursting strength. |
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