Pantoprazole Sodium Sesquihydrate

Pantoprazole Sodium Sesquihydrate

PURPOSE:  This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:  This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

• Master Copy : Manager Quality Assurance
• Copy No. 1 : Production Pharmacist
• Copy No. 2 : Manager Quality Control

Copy No. 3 : Non-β Lactam Capsule Section

 COMPOSITION

  Each Capsule contains

Pantoprazole Sodium Sesquihydrate

Equivalent to Pantoprazole                            20 m

(As enteric coated pellets

Domperidone Maleate                B.P.

Equivalent to Domperidone                           10 mg

 (As enteric coated pallets)

EQUIPMENTS TO BE USED:

RAW MATERIALS:

Packing materials:

MANUFACTURING SPECIFICATION:

1. Use number 2 size Pink/C.T. Capsules.
2. Moisture content of granules should be less than 2.0 %.
3. Average fill of each capsule is 272 mg.
4. Weight Variation Limit for average weight of 20 Capsules is +5 %
5. Disintegration time for each Capsule is not more than 15 minutes.
6. Average weight of twenty filled capsules is 6.68 grams.
7. Since Omeprazole is photo sensitive, all primary operations such as Batch Mixing, Filling, sorting and strip packing of Omimac capsule should be carried out in darkness and direct exposure to light should be avoided.

Temperature of primary area NMT 27° C and RH not more than 45%.

Yield:

1. Theoretical Yield is 1.0 Lac capsules.
2. Expected Practical Yield is 1.0 Lac ± 2% capsules.

Packing Details:

1. Strip Pack the filled and polished capsules by using Strip Packing Machine as per its SOP
2. Put single strip each containing 10 capsules into the unit carton.
3. Put 10 strips packed in unit carton each containing 10 capsules into the outer carton.
4. Seal the outer carton from both ends with cello tape.
5. Pack the 24 cartons in specified corrugated box T-16 to give a pack size of 24 x 10 x 10 capsules.
6. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label

  MANUFACTURING PROCESS: 

1. Transfer 14.018 kg of Pantoprazole pellets to Roto Cube Blender.
2. Transfer 2.750 kgs of Domperidone 10.400 kg of prepared Lactose granules to Roto Cube Blender and blend for 15 minutes by operating Roto Cube Blender as per SOP No. SOP/NB/003/MO/II.
3. Weigh the whole batch. The weight of whole batch should be in range of 71.80 kg – 72.5 kg.
4. Send the sample to Quality Control Department for bulk testing.
5. Start filling of Empty Hard Gelatin capsules, 272 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP 
6. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per its SOP 
7. Strip pack the filled capsules by using Strip Packing Machine as per its SOP 

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.

• Relative Humidity – Less than 45 %
• Temperature – 25 ⁰C ± 2 ⁰C

5. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
6. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
7. Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
8. Detect out of limit capsules by Weight Variation Method as follows:

1. a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

1.  Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
2.  Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.

9. Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
10. Inspection, sorting and polishing of filled capsules should be done as per SOP
11. Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
12. i) Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
13. i) The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

• ii) Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
• iii)The ass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
• iv) introduce tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.v
• v) Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

• vi) When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.

          Disintegration Time of filled capsules = Not more than 15 minutes

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