SOP on Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution.

0
585
1.0 Objective
To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant solution.
 2.0 Scope
This SOP is applicable for issuance, preparation, storage, usage and disposal of disinfectant solution in __________(Company/Place name location).
 3.0 Responsibility
GMP coordinator is responsible for the issuance of the disinfectant solution.
GMP coordinator shall responsible for receipt, storage, usage and disposal of disinfectant solution.
Head of concerned departments shall be responsible for implementation of the SOP.
 4.0 Accountability
Concerned Department Head & QA Head shall be accountable for the compliance of this SOP.
5.0 Abbreviations and Definitions
SOP                 :   Standard Operating Procedure
IPA                  :   Iso Propyl Alcohol
%                     :   Percentage
V/v                  :   Volume/Volume
W/v                 :   Weight/Volume
W/w                :   Weight/Weight
ml                    :   Milli Liter
SS                    :   Stainless Steel
Ltr.                  :   Litre
DM                  :   De-mineralized
GMP               :   Good Manufacturing Practices
BP/IP              :   British Pharmacopoeia/Indian Pharmacopoeia
6.0 Procedure
6.1 Usage of Disinfectant Solution:
6.1.1 Disinfectant solution shall be used for following:
Surface disinfection
Hand disinfection
Equipment sanitization
Spray disinfection
Dilute disinfectant solutions shall be used for cleaning in both manufacturing, packing and warehouse area.
6.2 Issuance of Disinfectant solution
6.2.1 All disinfectant solution except IPA shall receive by GMP coordinator and shall store in designated place.
6.2.2 IPA shall receive by warehouse.
6.2.3 Following disinfectant shall be used in premises for cleaning & sanitization:
S. No.
     Name of        disinfectant
    Concentration
                 Composition
     Application
    1.
         IPA
            70%
Isopropyl alcohol
Hands and Surface Disinfection.
   2.
Dettol Antiseptic Liquid
            2.5%
Chloroxyfenol I.P.4.8%w/v
Terpineol B.P.9.0%v/v
AlcoholAbsolute13.1%
Contains Caramel I.P as Colour
General Cleaning and Disinfection
   3.
Pursue
           0.8%
Diolkyl/dimethyl ammonium chloride and Alkyldimethylbenzyl ammonium chloride-3.8%
General Cleaning and Disinfection
   4.
Dazzl
          4.5%
Benzalkonium Chloride I.P. 4% w/v and Carmosine
General Cleaning and Disinfection
   5.
Cetrimide
           2%
Cetrimide
General Cleaning and Disinfection
6.
Savlon
   2.5 %
Chlorhexidine Gluconate – 5gm (0.3%w/v), Cetrimide – 15gm (3%w/v)
General Cleaning and Disinfection
  • 6.2.4 GMP coordinator shall issue disinfectant solution (except IPA) to housekeeping personnel on daily basis through material issue slip IPA shall be issued by warehouse to GMP coordinator through material issue slip.
    6.3 Distribution of disinfectant solution
    6.3.1 Intact container of disinfectant solution shall distribute to respective area.
    6.3.2 Distribution record disinfectant solution shall maintain in the “Receiving and distribution of Disinfectant Solution” (Annexure-I).
    6.3.3 Consumption record of disinfectant shall maintain area wise in the “Disinfectant Consumption and Destruction Record” (Annexure-II).
    6.3.4 The disinfectant solution shall be stored in the respective places in manufacturing, packaging and warehouse area.
6.4 Preparation of disinfectant solution shall be done as follows
6.4.1 After issuance disinfectant solution shall be prepared in respective area by housekeeping personnel in presence of area Incharge.
6.4.2 Disinfectant solution shall prepared & rotate on daily basis.
6.4.3 70% IPA solution shall be used as hand disinfection as such as it is available.
6.4.4 Dilution of other disinfectant solution shall be prepared as follows:
6.4.4.1 A clean fiber bucket shall be used for preparation of disinfectant dilute solution.
6.4.4.2 Required quantity of DM water & disinfectant (as mentioned in point 6.2.3) shall measure through graduated measuring cylinder and transfer to bucket.
6.4.4.3 To form a consistent solution, solution shall mix by using SS rod.
6.4.4.4 Dilution of disinfectant solution shall prepare as per requirement by using following standard:
S. No.
Name of Disinfectant
Concentration
 Volume to be      Prepared           (mL)
Volume of Disinfectant (mL)
Volume of DM Water (mL)
1.
Dazzl
        4.5% v/v
         10000
         450
        9550
2.
Pursue
       0.8% v/v
          80
       9920
3.
Cetrimide
       2% w/w
          200
        800
S. No.
Name of Disinfectant
Concentration
Volume to be Prepared                         (mL)
Volume of Disinfectant (mL)
Volume of DM Water (mL)
4.
Dettol Antiseptic Liquid
      2.5 % v/v
          10000
      250
    9750
5.
Savlon
       2.5 % v/v
      250
      9750
  • 6.4.4.5 Disinfectant preparation record shall maintain as per “Receiving and distribution of Disinfectant Solution” (Annexure-I).
    6.4.4.6 Distribution record of IPA shall maintain on same Annexure I.
 6.5 Disposal of Dilute Disinfectant Solution
6.5.1 After completion of the sanitization activity, discard the left over disinfectant solution by pouring the solution into nearest drain of respective area.
6.5.2 Record the consumption and destruction of disinfectant solution in the “Disinfectant Consumption and Destruction Record” (Annexure-II).
 6.6 Precautions
6.6.1 Protective wear is must while preparing the disinfectant solution.
6.6.2 Avoid spillage of disinfectant solution on the floor while preparation.
6.6.3 Do not use expired solution for cleaning.
 7.0 Forms and Records (Annexures)
7.1 Receiving and Distribution of Disinfectant Solution –           Annexure-I
7.2 Disinfectant Consumption and Destruction Record –           Annexure-II
 8.0 Distribution
8.1 Master copy –           Quality Assurance
8.2 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, and Human Resources.
9.0 History
            Date
 
Revision Number
                               Reason for Revision
          –
          –
                                                                                                           Annexure-I
                                                                          Receiving and Distribution of Disinfectant Solution
 
Name of Disinfectant_________________________             Use before Date_____________________
Date of Receiving
Quantity Received
Received  by
(Sign/Date)
Distributed by
 Name of Area
Issued Qty.
Received By
(Sign/Date)
Balance Quantity
Remarks
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Format No.
                                                                                                            Annexure-II
                                                                   Disinfectant Consumption and Destruction Record
 
Area Name________________                           Qty. of Disinfectant Standard Pack_______________
 
Name of Disinfectant____Concentration of Disinfectant Solution______Use before date_________
Date of Preparation
Qty. of DM Water
(Ltr.)
Qty. of Disinfectant Solution used
(Ltr.)
Total Qty. Prepared
(Ltr.)
Balance Quantity of Disinfectant
Prepared by
(Sign & Date)
Remaining Qty. Destroyed by (Sign & Date)
Checked by
(Sign & Date)
 Format No:

LEAVE A REPLY

Please enter your comment!
Please enter your name here