Drugsformulations
Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution in Pharma Industry
- Objective
To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant solution in Pharma Industry.
- Scope
This SOP is applicable for issuance, preparation, storage, usage and disposal of disinfectant solution in manufacturing area in Pharma Industry.
- 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.
- Accountability
- Concerned Department Head & QA Head shall be accountable for the compliance of this SOP.
- 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
PW : Purified Water
GMP : Good Manufacturing Practices
BP/IP : British Pharmacopoeia/Indian Pharmacopoeia
- Procedure
- Usage of Disinfectant Solution:
- 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.
- Usage of Disinfectant Solution:
- Issuance of Disinfectant solution
- All disinfectant solution except IPA shall receive by GMP coordinator and shall store in designated place.
- IPA shall receive by warehouse.
- 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 |
- GMP coordinator shall issue disinfectant solution (except IPA) to concerned personnel on daily basis through material issue slip, IPA shall be issued by warehouse to GMP coordinator through material issue slip.
- Distribution of disinfectant solution
- Intact container of disinfectant solution shall distribute to respective area.
- Distribution record disinfectant solution shall maintain in the “Receiving and distribution of Disinfectant Solution” (Annexure-I).
- Consumption record of disinfectant shall maintain area wise in the “Disinfectant Consumption and Destruction Record” (Annexure-II).
- The disinfectant solution shall be stored in the respective places in manufacturing, packaging and warehouse area.
- Preparation of disinfectant solution shall be done as follows
- After issuance disinfectant solution shall be prepared in respective area by concerned personnel in presence of area Incharge.
- Disinfectant solution shall prepared & rotate on daily basis.
- 70% IPA solution shall be used as hand disinfection as such as it is available.
- Dilution of other disinfectant solution shall be prepared as follows:
- A clean fiber bucket shall be used for preparation of disinfectant dilute solution.
- Required quantity of purified water & disinfectant (as mentioned in point 6.2.3) shall measure through graduated measuring cylinder and transfer to bucket.
- To form a consistent solution, solution shall mix by using SS rod.
- 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 Purified 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 Purified Water (mL) |
| 4. | Dettol Antiseptic Liquid | 2.5 % v/v | 10000 | 250 | 9750 |
| 5. | Savlon | 2.5 % v/v | 250 | 9750 |
- Disinfectant preparation record shall maintain as per Disinfectant Consumption and Destruction Record” (Annexure-II).
- Distribution record of IPA shall maintain on same Annexure I.
- Disposal of Dilute Disinfectant Solution
- After completion of the sanitization activity, discard the left over disinfectant solution by pouring the solution into nearest drain of respective area.
- Record the consumption and destruction of disinfectant solution in the “Disinfectant Consumption and Destruction Record” (Annexure-II).
- Precautions
- Protective wear is must while preparing the disinfectant solution.
- Avoid spillage of disinfectant solution on the floor while preparation.
- Do not use expired solution for cleaning.
- Forms and Records (Annexures)
- Receiving and Distribution of Disinfectant Solution – Annexure-I
- Disinfectant Consumption and Destruction Record – Annexure-II
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, and Human Resources.
- History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
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 | Issue Qty. | Received By (Sign/Date) | Balance Quantity | Remarks |
Annexure-II
Area Name________________ Qty. of Disinfectant Standard Pack_______________
| Date of Preparation | Qty. of purified 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) |
Corrective and Preventive Action (CAPA) In Pharma Industry
