Rinse water Analysis

1.0 OBJECTIVE

To lay down a procedure for sampling rinse waters during product change over from cleaned equipment's like vessels, flasks and filling syringes etc. used for manufacturing of sterile products.  

2.0 SCOPE          

This procedure is applicable for all equipment's and accessories used for   manufacturing of sterile products at COMPANY NAME.  

3.0 RESPONSIBILITY    

3.1Chemist – Quality Assurance  

4.0 ACCOUNTABILITY   

4.1  In charge – IPQA  

5.0 PROCEDURE 

Note: Collect the rinse samples only during product change over. If the equipment/vessels are used for the same product, rinse water samples are not required  

5.1 Equipment's used for sterile products should be so designed to facilitate cleanability and permit visual inspection and whenever possible the equipment must be made of smooth surfaces of non-reactive material. 

5.2  Rinse water sampling procedure is performed to verify the effectiveness of cleaning procedures for removal of the product residues and cleaning agents and to ensure that there is no risk associated with cross contamination of active ingredients.  

5.3  Following is the procedure for routine inspection and verification of cleaning of  equipment used for sterile products at different stages.  

5.3.1 Cleaning of equipment's and components shall be carried out by production personnel under the supervision of manufacturing chemist responsible for component preparation area. 

5.3.2  At the end of the production run various parts that come in contact with the product shall be dismantled and cleaned in the washing cubicle in the component preparation area. 

5.3.3 Operator shall clean all the equipment's, vessels and accessories as per SOP and filling assembly as per SOP.  

5.3.4 Final rinse shall be given with hot WFI.  

5.3.5 Visual inspection is carried out before sampling the rinse water to ensure that the equipment including hard to clean areas appear clean with no traces of product or cleaning agent.  

5.3.6 Clean the contact and non-contact parts with 0.1 % Teepol solution if required 

5.3.7 Rinse water sample shall be sent to Q.C Lab for analysis and record. 

5.3.8 Testing and documentation of rinse water samples shall be carried out as per SOP.

5.3.9 Clearance / Approval for use of the equipment for production shall be given by IPQA chemist after receiving the QC rinse water analysis report (Annexure – II) and recording in the record as approved. 

 5.4 Storage of equipment  

5.4.1 Washed equipment and components shall be sterilized on the same day. 

5.4.2 Equipment which may not be used immediately, shall be dried and wrapped carefully 

5.4.3 Store the equipment (when not in use) in equipment storage area, which should be duly labeled for which product it is used, cleaned by, cleaned on, checked by and also a note “To be rinsed with WFI again before use”. 

5.4.4 All the wrappings with parchment paper shall be carried under LAF of component preparation area.

 6.0 ANNEXURES

Annexure I: Rinse water Analysis Record

Annexure II: Rinse water analysis report

Annexure III: Rinse water sample for Analysis 

7.0 CHANGE HISTORY