Name __________________________ Date ___________________Section ______________ Group No. ______________

Exercise No. 8----------------------------------------------------------------

M.O. #____________MARY IMMACULATE PHARMACY

Fr. Selga St.Davao City

MANUFACTURING ORDER

Product: CHLORAMPHENICOL PALMITATE Manufacturing:

Batch Size______________ Date Started____________

Batch Number____________ Date Finished___________

Expiry Date_____________

----------------------------------------------------------------Control Item Ingredients Amount per X –numbers Code # 120 liters_______ ______ Chloramphenicol

Palmitate 5 kg _______________ ______ Carboxymethyl 1 kg ________

Cellulose Na_______ ______ Methyl Paraben Na 240 g _______________ ______ Propyl Paraben Na 60 g _______________ ______ Tween 20 120 ml _______________ ______ Sugar 60 kg _______________ ______ Sodium Citrate 120 g _______________ ______ Citric Acid 220 g _______________ ______ Raspberry Flavour 220 g _______________ ______ Glycerin 2.5 lit. _______________ ______ Purified Water q.s. 120 lit. ________----------------------------------------------------------------

Manufacturing Specifications:

1. Use 60 ml Amber Glass Bottles.2. PH should be between 4.5 and 7.0.3. 174 mg of Chloramphenicol Palmitate is equivalent to 100 mg

of Chloramphenicol.

Prepared by __________________ Approved by _________________Date ________________________ Date ________________________

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MARY IMMACULATE PHARMACYFr. Selga St.Davao City

MANUFACTURING BATCH RECORD

Product: CHLORAMPHENICOL PALMITATEORAL SUSPENSION Manufacturing:

Batch Size __________________ Date Started ______________

Batch Number ________________ Date Finished _____________

Expiry Date _________________

I. SOP PRIOR BATCH PROCESSING

1. All ingredients must be checked and approved by Q.C. Prior to use.

2. All ingredients must be labeled properly. Weights and volume must agree with the approved M.O.

3. All equipment and accessories must be cleaned.4. Processing room must be cleaned.5. Wear necessary protective garments.

II. CLEAN ROOM AND EQUIPMENT CHECK:Cleaned by Checked by

Liquid Manufacturing Room ---------- ---------Required Equipment ---------- ---------

III. MANUFACTURING PROCEDURE:

A. 1. Heat 30 lit. (________) of Purified Water to 60°C in a SS vessel and dissolve Methyl Paraben Sodium and Propyl Paraben Sodium (half quantity).By _____________________ Checked by ________________

2. Add 60 kg (________) sugar under constant stirring and raise the temperature to boiling point.

By ____________________ Checked by _________________

3. Add Citric Acid and Sodium Citrate to the hot syrup and filter.

By ____________________ Checked by _________________

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Product: CHLORAMPHENICOL PALMITATE Batch Size ___________ORAL SUSPENSION Batch NO._____________

---------------------------------------------------------------4. Allow to cool to room temperature by keeping it overnight.

By ____________________ Checked by _________________

B. 1. Mix Glycerin with CMC solution in an SS vessel to form a smooth paste.

By ____________________ Checked by _________________

2. Add Tween 80 and again stir well to form a thin paste.

By ____________________ Checked by _________________

3. To a SS tank, transfer 50 lit. (_______) of filtered water and heat to 60°C.

By ____________________ Checked by _________________

4. Dissolve Methyl Paraben Sodium and Propyl Paraben Sodium (half quantity).

By ____________________ Checked by _________________

5. Add 100 g (________) Citric acid and 60 g (_________) Sodium Citrate and stir till completely dissolved.

By ____________________ Checked by _________________

6. To this hot water solution add the Glycerin-CMC Sodium-Tween 80 paste slowly under constant stirring. Continue till completely dissolved. Allow to cool to room temperature.By ____________________ Checked by _________________

C. 1. Start stirring the mixture of Step B. In case the jelly is thick and does not move add more quantity of filtered syrup from Step A and water till the whole mass is moving with the stirrer.

By ____________________ Checked by _________________2. To this mass add Chloramphenicol Palmitate in small

quantities and suspend uniformly.By ____________________ Checked by _________________

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Product: CHLORAMPHENICOL PALMITATE Batch Size ___________ORAL SUSPENSION Batch NO._____________

---------------------------------------------------------------

3. Add the syrup from step A along with Chloramphenicol Palmitate and Purified Water.

By _____________________ Checked by _________________

4. Continue stirring and make up the volume.

By _____________________ Checked by _________________

5. Allow to stand overnight.

By _____________________ Checked by _________________

6. Check the volume and adjust.

By __________________ Checked by _________________

7. Add Raspberry Essence and stir thoroughly.

By __________________ Checked by _________________

IV. BARCH SAMPLING: (Show Computation)

Sample Size _________________

Sample by ___________________

Date ____________________Time ____________________

Results _____________________ ______________________ ______________________

Verified by ________________

Disposition ________________

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V. BATCH RECONCILIATION (show Computation)

Sample _____________ (__________ %)

Net Yield __________ (__________ %)

Gross Yield ________ (__________ %)

Loss/ Overage ______ (__________ %)

COMPUTATION:

Give the role of each ingredients in the formulation:

Ingredients Role of IngredientsChloramphenicol Palmitate _____________________________

Carboxylmethyl Cellulose Na _____________________________

Methyl Paraben Na _____________________________

Propyl Paraben Na _____________________________

Tween 20 _____________________________

Sugar _____________________________

Sodium Citrate _____________________________

Citric Acid _____________________________

Raspberry Flavour _____________________________

Glycerin _____________________________

Purified Water q.s. _____________________________

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