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SEVEN STEPS TO SUCCESS IN CAPSULES

Introduction

1. Packaging of Empty Capsules

2. Transportation of Empty Capsules

3. Inspection of Capsules on Receipt

4.Warehousing/Storage

5. Capsule Filling

6. Packaging of Filled Capsules

7. Shipping of Filled Capsules

Introduction:

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.

1. Packaging Of Empty Capsules:

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).

2. Transportation of Empty Capsules:

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.

3. Inspection of Capsules on Receipt:

Inspect your shipment on arrival. The following are examples of heat damage during transportation:

bulletCapsules are smaller in size (average length less than lower tolerance limit) or vary in size.
bulletCapsules are stuck together in lumps and do not come apart.
bulletCapsules are brittle or shatter very easily during handling or filling.
bulletCapsules are severely distorted in shape.
bulletCapsule cap is stuck to body and resists separation.

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:

 

Min.

Ideal

Max.

Relative Humidity

35%

50%

65%

Temperature

15 C

20 C

25 C

59 F

68 F

77 F

 

bulletStore capsules away from direct sunlight (e.g. windows and skylights) as it can raise the surface temperature of a carton to 150F.
bulletStore capsules away from hot water/air radiators, hot water pipes and steam pipes.
bulletStore capsules on pallets off the ground.
bulletStore capsules away from potential sources of water condensation e.g. under water pipes.
bulletDo not store empty capsules in freezers.

The effect of prolonged storage (over a few days) in areas outside the recommended conditions may cause the damage indicated in the table below:

Damage to Capsule

Probable Cause of Damage

Effect on Capsule Moisture

Softening and loss of shape

Storage at high R.H.

Increased

Difficult to separate; capsules form lumps; visible condensation on surface of bag.

High temperature or temperature cycling during storage.

Decreased

Capsules shrunk in size; shatter when pressure applied.

Storage at low R.H.

Decreased

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.

bulletIt is important during filling and packing to keep empty and filled capsules covered when not being filled to minimize moisture loss or gain.
bulletSeal or tie bags containing empty capsules during shift breaks or at the end of shifts.
bulletStore filled capsules in plastic drums with lids until they are packed in final container.

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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