procedure for Replacement of Brine Solution of Homogenizer Chiller
1.0 OBJECTIVE :
1.1 To lay down a procedure for Replacement of Brine Solution of Homogenizer Chiller.
2.0. SCOPE :
2.1 This procedure is applicable to replacement of brine solution of homogenizer chiller situated at pharma Dekho
3.0. RESPONSIBILITY :
3.1 Operator shall be responsible for the replacement of brine solution of homogenizer chiller.
3.2 Officer/Executive Engineering Department shall be responsible for to verify the replacement of brine solution of homogenizer chiller.
3.3 Quality control personal will be responsible for analysis of Specific gravity.
4.0. ACCOUNTABILITY :
4.1 Head Engineering Department shall be accountable for compliance of SOP.
5.0. PROCEDURE :
.
5.1 PRIMARY CHECKS:
5.1.1. Ensure that the availability of Glycerol 25 Liter.
5.1.2. Ensure that the Circulation pump & Chiller is switched ‘Off’.
5.1.3. Display the ‘Under Maintenance Board’.
5.2. PROCEDURE:
5.2.1 Open the top cover of Homogenizer Chiller tank.
5.2.2 Take out the Brine Solution from tank.
5.2.3 Properly clean the tank inside with purified water.
5.2.4 After cleaning of tank, load the new solution of brine of 75 Liter purified water and 25 Liter Glycerol in 100Ltrs of Tank.
5.2.5 Take 5 ml sample of new solution of brine and check the specific gravity by authorized person of QC and Log in the Annex-II.
5.2.6 Specific gravity of new solution of brine shall be more than 1.04 then close the top cover.
5.2.7 After closing the tank of Homogenizer Chiller, run the Homogenizer Chiller for 2 hours and takes the reading of temperature at every 15 min. & fill the Temp. record as per Annex-III.
5.2.8 If the Homogenizer Chiller achieves the Set Temperature successfully at 15 min reading & continued for the rest of time.
5.2.9 Frequency of replacement of brine solution of homogenizer chiller : Quarterly
5.2.10 Fill the replacement record of brine solution as per Annex-I.
6.0. ABBREVIATION :
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1 | SOP | Standard operating procedure |
| 2 | EM | Engineering and maintenance |
7.0 ATTACHMENTS (ANNEXES) :
7.1 Annex-I: Homogenizer Chiller Brine (Glycerol + Water) Replacement Record.
7.2 Annex-II: Specific Gravity of 5 ml Brine Solution.
7.3 Annex-III: Homogenizer Chiller Temp Monitoring Log.
8.0. REFERENCE :
In House
Annex-I: Homogenizer Chiller Brine (Glycerol + Water) Replacement Record
Annex-II: Specific Gravity of 5 ml Brine Solution.
Annex-III: Homogenizer Chiller Temp Monitoring Log.
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procedure for Replacement of Brine Solution of Homogenizer Chiller