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SACHET FILLINGEQUIPMENT

INSTRUCTION MANUAL

DISCLAIMER: For use in prescription pharmacy compounding only, in accordance with applicable law. Medisca makes no warranty or representation regarding the use of this product or fitness for any particular purpose, and any such use is entirely the responsibility of the pharmacist in the exercise of his/her professional expertise and judgment. Accordingly, in no event will Medisca be liable for any damages from the use or misuse of the product. Purchaser’s sole remedy in the event of product defect or other damages shall be the refund of the purchase price of the product.

This manual is intended for use by qualified compounding personnel engaged in the service, inspection, maintenance and handling of the equipment.

INDEX

SECTION A: Sachet Filling Equipment – Components . . . . . . . . . . . . . . . . . . . . . . . . 3

SECTION B: Sachet Filling Equipment – Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SECTION C: Related Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

SECTION D: Sachet Filling Equipment – Cleaning & Maintenance . . . . . . . . . . . . . . 7

2 • SACHET FILLING EQUIPMENT INSTRUCTION MANUAL


SECTION A: Sachet Filling Equipment – Components MEDISCA’s Sachet Filling Equipment represents a simple, fast, and convenient way of dispensing batch sizes of powder formulations. Specifically designed for MEDISCA’s Effervescent Delivery System, this equipment allows the pharmacist to produce medicated powder formulations with high palatability, a wide range of dosages and accurate dosing even at high drug loading content. Simply choose the desired bin volume then load the pre-mixed powder into the sachet filling equipment for uniform fill weights.

1

2

3

4

5 6

7

1

2

3

4

5

6

7Cavity Plate

Base Stand

Base Plate

2 x Spacer

4 x Rubber Stoppers

32 x 2 .5 mL Bins, 32 x 5 .0 mL Bins, 32 x 7 .5 mL Bins, 32 x 10 .0 mL Bins

Powder Scraper

SACHET FILLING EQUIPMENT INSTRUCTION MANUAL • 3


SECTION B: Sachet Filling Equipment – Assembly

1) Adjusting the Base Plate

Place the Base Plate onto the Base Stand through the four protruding metal rods located in the corners of the Base Stand .

4) Insert Rubber Stoppers

Gently place the rubber stoppers on top of the Cavity Plate and the four protruding metal rods .

3) Install the Cavity Plate

Add the Cavity Plate on top of the Spacers through the four protruding metal rods on the corners of the Base Stand .

2) Adjusting the Spacer

Put one Spacer at the top and bottom of the Base Stand and ensure the Spacers are standing upright lengthwise (not flat down).



5) Insert Plastic Bins

Drop the desired size plastic Bins in the corresponding holes of the Cavity Plate .

8) Remove excess FizzMix Powder Blend

If applicable, remove excess powder into a Mortar . Do not tap the cavity plate .

6) Pour in FizzMixTM Powder Blend

Pour the pre-weighed blend containing FizzMix Base, APIs and Flavor, onto the Cavity Plate .

7) Distribute FizzMix Powder Blend Evenly

Use Powder Spreader to spread powder from center towards all 4 edges of the Cavity Plate .



9) Retrieving the Plastic Bins

Use both hands and turn the Spacers so that they are facing flat down. This will cause the Cavity Plate to sink and expose the Bins filled with powder .

12) Labeling

Place the appropriate label on the Moisture Barrier Bag and dispense to your patient .

10) Packaging FizzMixTM Contents

Pour each Bin in to a single appropriately sized Moisture Barrier Bag .

11) Sealing FizzMix Contents

Use an Impulse Sealer (with a two second timer) to seal the bag. Inspect the seal and repeat if necessary for a better seal .



SECTION C: Related Products• 6588: Bins (PE), Sachet Filling, 2.5 mL• 6591: Bins (PE), Sachet Filling, 5.0 mL• 6587: Bins (PE), Sachet Filling, 7.5 mL• 6589: Bins (PE), Sachet Filling, 10.0 mL• 6594: Bag, Moisture Barrier, Flat, w/Tear Notch, 70x80 mm• 6590: Bag, Moisture Barrier, Flat, w/Tear Notch, 100x80 mm• 6593: FizzMix™ Base• 9813: Impulse Sealer (Small) 8“• 2000: Apple Flavor• 2851: Passion Fruit Flavor• 2852: Raspberry Flavor• 2853: Orange Flavor• 2854: Mango Flavor

SECTION D: Sachet Filling Equipment – Cleaning & Maintenance1. Rinse the Cavity Plate, Bottom Plate and Bins under warm running water . 2. Base stand, spacer and rubber stopper must be cleaned adequately – Not dishwasher safe .3. Soak the Bins in warm soapy water for a few minutes to facilitate cleaning . Bins are recommended for single

use to prevent cross- contamination .4. Wash the equipment using warm water, liquid soap and a soft brush or sponge .5. Thoroughly rinse and drain off cavity plate, bottom plate and bins.6. Use 40% alcohol for a final wipe down.7. Let dry .

ATTENTION: Avoid the use of metal utensils (spoon, spatulas, scraper,

brush, etc.) and cleaning aids with abrasive surfaces due to the potential

risk of damaging the coating. Dishwasher can be used for Cavity Plate,

Bottom Plate and Bins with all the above precautions.



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