MANUFACTURING PROCEDURE

SULTAMICILLIN TABLETS 375MG

COMPOSITION:
Each tablet contains:
Sultamicillin Tosylate Dihydrate BP
Eq to Sultamicillin......................375 mg
Excipients………………………q.s
S. no Name of Ingredients Function of Quantity Overage Quantity Water/L Total
ingredients required (%) required OD quantity
per tab per tablet content required per
(%) tablet
Active
1. Sultamicillin Tosylate Active 506.0 mg. Nil 506.0 mg. Nil 506.0 mg.
BP Ingredient
Inactive
2. Aerosil ( Collidol Diluent 6.500 mg Nil 6.500 mg Nil 6.500 mg
Silicondioxide) BP
3. Lactose BP Diluent 86.570 mg Nil 86.570 mg Nil 86.570 mg
4. PVP K-30 BP Binder 3.800 mg Nil 3.800 mg Nil 3.800 mg
5. Sodium Lauryl Sulphate Surfactant 9.00 mg Nil 9.00 mg Nil 9.00 mg
BP
6. Cros Povidone BP Disintegrant 11.00 mg Nil 11.00 mg Nil 11.00 mg
7. Croscarmellose Sodium Disintegrant 6.500 mg Nil 6.500 mg Nil 6.500 mg
BP
8. PEG 6000 BP Solubilizer 12.00 mg Nil 12.00 mg Nil 12.00 mg
9. Purified Talc BP Solvent 3.750 mg Nil 3.750 mg Nil 3.750 mg
10. Magnesium Stearate BP Glidant 4.880 mg Nil 4.880 mg Nil 4.880 mg
Avg. weight of uncoated tablet : 650 mg
 FILM COATING INGREDIENTS:

Name of Ingredients Quantity (per tablet) Total quantity required

Methylene dichloride BP 156.00 mg 156.00 mg
Isopropyl Alcohol BP 104.0 mg 104.0 mg
PEG-6000 BP 1.300 mg 1.300 mg
HPMC E-15 BP 6.500 mg 6.500 mg
Color Titanium dioxide BP 4.550 mg 4.550 mg

Di-Ethyl Phthalate (Dep) BP 1.300 mg 1.300 mg

Purified Talc BP 3.250 mg. 3.250 mg.

Avg. weight of tablet after film coating: 663 mg.
Loss during film coating per tablet = 6.50 mg.

Calculation:
Molecular weight of Sultamicillin tosilate = 802.9 g/mol
Molecular weight of Sultamicillin = 594.659 g/mol
Factor: 802.9/594.659 x 375 = 506 mg of Sultamicillin tosilate is eq. to 375 of Sultamicillin.

Approved By Prepared By
(Ravinder Singh) (Manjit Singh)
Q.A. Manager Manufacturing Chemist
 MANUFACTURING PROCEDURE FOR 157000 TABLETS:

Stage Procedure Type of process

Sifting Mix 79.442 kg Sultamicillin and 1.020 kg Aerosil (Collidol Non-Critical
Silicondioxide) for 10 mints and sift through 80#. Sift 13.59 kg
lactose, 596.6 gm PVPK-30, 1.413 kg Sodium Lauryl Sulphate,
1.727 kg Crospovidone, 1.020 kg Croscarmellose sodium and 1.884
kg PEG 6000 through 60#
mixing Again mix the sifted material for 10mints. Critical
Add 13.59 kg lactose, 596.6 gm PVPK-30, 1.413 kg Sodium Lauryl
Sulphate, 1.727 kg Crospovidone, 1.020 kg Croscarmellose sodium
and 1.884 kg PEG 6000 one by one in above mixed material and
rotate the blender for 20 mints.
After that add half Purified talc and half magnesium stearate and go
for slugging. (Slugging hardness 5-6 kg/cm²).
Sifting Slugging material sift through 24# and mix for 10mints. Non-Critical
Lubrication At last add remaining Purified talc and magnesium stearate and mix Critical
for 8mints.
Compression Compress at average weight 650 mg. Critical

Batch size for coating: 34.01 kg./ 52333 tablets x 3 cycles

Coating 1. Mix all the solid ingredients with 5.442 kg IPA and 8.163 kg Critical
methylene dichloride in a mixing vessel
2. Now colloid the mixed solution in colloidal mill for 30 min
3. Now use this prepared solution for 34.01 kg uncoated tablets.
4. Repeat step from 1 to 3 for remaining 2 cycle.
Labeling and Packing

The tablets are packed in Blister strip by strip machine. The machine is made to average tablets 80000
tablets per hour. Manufacturing Chemist checks the colour and average weight of tablets. Before packing
whole Batch sample of tablets brought into the Quality control Department. For quality assurance after
permission of quality Analyst, Further packing carried out.

In process Control
All the in-process analysis were already mentioned in flow sheet which includes i) made sure that all the
input are tested, ii) weight of input is cross checked by manufacturing chemist, iii) Average weights are
checked by manufacturing chemist.

During packing, samples are drawn & send to the QCD for Analysis. The packed materials are kept in
Quarantine finished store. On receiving Analysis report Ok from the QCD, the goods are sent to finished
goods store.
MANUFACTURING FLOW CHART

Dry
RM Sifting Mixing
RM dispensing Granulation
Verification at
mfg. stage

QC Sample intimation Milling

for bulk uniformity

Drying

Dried granules
sifting

Lubrication
QC Sample
intimation for semi-
finished Compression

QC Sample
intimation for semi- Coating
finished

QC Sample Packing
intimation for
finished product
Transfer to B.S.R

Dispatched
 GOOD MANUFACTURING PRACTICES
To ensure a quality product, all current good manufacturing practices should be followed such as:
1. AREA AND EQUIPMENTS:
1. The area should be free from unwanted material as well materiel from the last batch.
2. The equipments to be used are labeled for product, batch no. and date prior to use.
3. The equipments to be used bear a “clean equipment bag and wash water analysis report releasing the
equipment is available in case of product change over.

2. PERSONNEL:
1. All personnel should be of good health and should practice good sanitation habits.
2. Persons engaged in the manufacture, processing, packing or holding of drug product should wear
protective apparent such as head, face, hand and arm covering, necessary to protect the product from
contamination.

3. RAW MATERIAL AND PACKING MATERIAL:

1. All ingredients and packing material must be tested for conformance to written specifications.
2. Weight and volume of the ingredients should be checked by the authorized persons.

4. PRODUCTION AND PROCESS CONTROL:

1. Production record must be complete and accurate reflecting all the procedure and process adopted
during production.
2. Batch should be fabricated strictly as per the written procedure.