Page x of y

EDITION: 1-5-98

CLAMPRS CORPORATED

BATCH MANUFACTURING FORMULA, METHOD and RECORD

DEXTERIUM ADIPATE OINTMENT BATCH No. 102030

2.5%
Form: ANHYDROUS OINTMENT Batch Size: 2000 kg
PROCESS START AND COMPLETION TIMES
START: TIME: 7:15 am COMPLETION: TIME: 7:25 PM
DATE: September 07, 2020 DATE: September 08, 2020

FORMULA AND WEIGHING RECORD

CODE MATERIAL AMOUNT LOT No. DISPENSED CHECKED

BY: BY
123 White Soft 1750.00 10 H. L L.C
Paraffin UP
…
Name of Dispenser ____J. A________________ Initials________ Name of Checker ____S. P__________________ Initials ___

MANUFACTURING LOCATION: Processing room no. 5b. Block C

MAJOREQUIPMENT: Dedicated ointment manufacturing equipment-

OINIMILL KZ3 MILL- E132001
Steam-jacketed PZ/2 S/S Mixing Vessel, fitted with HITECH 2 Stirrer
Mobile S/S holding tank
Dedicated transfer pipework and pump

Batch document issued by: _____C. R_________ Date: September 07, 2020________

MASTER DOCUMENT SUPERSEDES:

EFFECTIVE 1-5-98 10-7-95
Prepared by: C. M Approved by: X.S Production: S.P

Date: September 07, 2020 Date: September 15, 2020 Date: September 20, 2020
 Page 2 of 2
Page 2 of 3
EDITION: 1-5-98
BATCH MANUFACTURING FORMULA, METHOD and RECORD

DEXTERIUM ADIPATE OINTMENT BATCH No. 102030

2.5%
Form: ANHYDROUS OINTMENT Batch Size: 2000 kg

MANUFACTURING INSTRUCTIONS AND RECORD

Name of Operator ____C. M____________________ Initials_______ Name of Checker ___H. L__________ Initials________

DATE TIME OPERATOR CHECKER

1. Check the Plant Log, and enter details of September 7:15 am X. S J. A
following: 07, 2020
1.1 Previous equipment use:
Product:
Batch No.
Date
1.2 Last equipment cleandown
Date:
2. Obtain clearance from Production September 9:36 am X. S J. A
Supervisor and QC that equipment is clean 07, 2020
and ready for use
Maintenance
QC clearance
Prod. Supervisor clearance
3. Add the 50.00 kg Dexteriun adipate to September 1:25 pm C. R S. P
the 200.oo kg heavy liquid paraffin in a 07, 2020
clean stainless steel container and stir by
hand, using a stainless steel rod
Stirring Start time
Stirring End time
4. Immediately transfer the slurry to the September 3:18 pm C. R S.P
KZ3 mill. 07, 2020
5. Mill at Medium speed setting for 15
minutes
Mill start time
Mill stop time
…7. What is the temperature of the molten September 6:30 pm L. C J. A
white soft paraffin reaches 70 to 75 C close 07, 2020
the steam valve and commence stirring at
speed setting 5. Record the temperature of
the melt:
Temperature ________________
 Page 3 of 3

Page 3 of 4

EDITION: 1-5-98
BATCH MANUFACTURING FORMULA, METHOD and RECORD

DEXTERIUM ADIPATE OINTMENT BATCH No. 102030

2.5%
Form: ANHYDROUS OINTMENT Batch Size: 2000 kg

MANUFACTURING INSTRUCTIONS AND RECORD (Contd.)

DATE TIME OPERATOR CHECKER

13. Pump ointment to tared mobile 8:47 pm L. C J. A
stainless steel holding tank September,
07, 2020
14. Weigh holding tank (and contents) on
floor scales, record gross weight, and enter
net yield of bulk ointment September 10:05PM L.C J. A
Gross weight ( tank 07, 2020
+Ointment)_________
Tare
_________
Yield of bulk ointment
_________

STANDARD ACCEPTABLE BULK YIELD – 1950 TO 2050 KG

15. Arrange for Sample of bulk product to be taken by Q.C sampler

C. M

AUTHORIZED DEVIATIONS FROM STANDARD PROCEDURE:

PROIR AUTHORIZATION: Production H. L Date: September 07, 2020 QC: X. S Date: September 07,
2020

NON-STANDARD EVENT RECORD (Include explanation of any non-standard yield):

PRODUCTION CERTIFICATION: Apart from any authorized deviations, or non-standard events,as

recorded above, this batch has been manufactured in accordance with this BATCH MANUFACTURING
FORMULA, METHOD, and RECORD.

Signed: C. M Production Supervisor

Date : September 07, 2020
QUALITY CONTROL APPROVAL FOR PACKAGING

This bulk batch of DEXTERIUM ADIPATE OINTMENT 2.5%. Batch No. _________________________
Has been sampled and tested, and is RELEASED FOR PACKAGING.
Signed : X. S Quality Control
Date: September 10, 2020

Page 4 of 4