Liquid Mixing Tank

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1.0 Purpose 
 
 The purpose of this procedure is to define the process for the setup, operation, and cleaning of
 the liquid mixing tanks. 
 
 2.0 Scope 
 
 This procedure applies to the liquid mixing tanks in operation at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of Production (Blending) personnel to follow this procedure.
 
 3.2 ‘It is the responsibility of the Department Supervisor/Manager to implement this
 
 procedure and to ensure that the procedure is being followed 
 
 3.3. ‘It is the responsibility of Production and/or Maintenance & Engineering to keep this
 
 procedure aligned with current practices. 
 
 4.0 Definitions 
 
 4.1 DI Water — Deionized Water 
 
 4.2 PPE — Personal Protective Equipment 
 
 5.0 References 
 
 Set B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
 
 5.2 B-103, SOP, Small Parts Cleaning and General Sanitation 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Liquid Mixing Tank B-401 2 =| Page 2 of 3 
 
 3:3 B-105, SOP, Preparation of Cleaning and Sanitizing Chemicals for Production
 
 6.0 Procedure 
 
 6.1 Setup and Operation 
 
 6.1.1 Inspect the entire mixer to ensure that it has been cleaned and sanitized before
 
 use. 
 
 If the tank has mixing components inside of it, ensure that they are cleaned and
 
 sanitized. If the tank does not have the mixer components inside of it, a portable
 
 mixer, shaft, and impeller can be mounted at the top and attached to the wall of
 the tank. Ensure if a portable unit is added, that all components are also cleaned
 
 and sanitized before adding. 
 
 6.1.3 Attach the discharge valve to the tank with a gasket and a tri-clover clamp.
 
 Ensure the valve, gasket, and clamp are cleaned and sanitized. Also ensure the
 gasket is in good condition with no rips/tears in it and that the clamp tightens as
 
 it should. 
 
 6.1.4 The discharge valve is an open/close sanitary ball valve. The ball valve should
 be in the closed position before charging raw materials into the tank.
 
 6.1.5 Closely follow the mixing instructions in the BPR and ensure all the proper
 components are being added. Be sure that is water is needed, the DI water is
 
 used. 
 
 Once the blend is complete and signed off by the QC laboratory, a clean and
 
 sanitized hose is tri-clamped to the tank ball valve and transferred to a either a
 holding tank or directly to the liquid filler machine. 
 
 6.2 Cleaning 
 
 6.2.1 Prepare cleaning agents as outlined in SOP B-105 Preparation of Cleaning and
 
 Sanitizing Chemicals for Production. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Liquid Mixing Tank B-401 Page 3 of 3 
 
 6.2.2 Follow SOP B-111 Cleaning of Manufacturing/Production Areas and
 
 Equipment and SOP B-103 Small Parts Cleaning and General Sanitation to
 
 ensure proper cleaning and sanitization are performed for this type of equipment
 and that these activities are properly documented. 
 
 6.2.3 There are no disassembly requirements or unique cleaning steps for this piece of
 equipment. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/22/15 | New Scheduled review: Removed obsolete definitions. Added reference to ‘ 1 21/1419 sop B-111 and SOP B-103. Revised section 6.2. 10082. B Buns Additional operational notes added. Changed responsibilities section. | 15-0219 | M. Wienke |
| 2 | 03/07/23 | Changed cleaning section and added SOP references. Updated logo CC- and format. | 23-0111 | M. Busse |