IMB Ribbon Blenders

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1.0 Punpose 
 
 This procedwre defines the process for setup, operation, and clearing of the IMB Ribbon
 Blenders. 
 
 2.0 Scope 
 
 This procedure applies to the IMB Ribbon Blenders in operation at ION Labs.
 
 3.0 Responsibility 
 
 3.1 Itis the respomsibility of a production (blending) personnel to follow this procedure.
 
 22 It is the regposdibility Of the depatinvatt supervisor r t© implement this
 procedure and to ensure that this procedure is being follwed. 
 
 833 itis the respomsibility of all operators to immediately report any equipment which is
 malfunctionimg, or not working to the department supervisor. 
 S44 itis the responsibility of all department Supervisors to immediately report any
 
 equipment malfunctionimg, not working, or any safety concen to the EHS Manager.
 Maintemamce and the Facilities Manager for an operational disposition.
 835 itis the responsibility of the supervisor to create a work order which willl clearly and
 spauifically document the level of pdoxity for the repair. The supervisor will ensure a
 system generated Work Order has been successfiully entered by obtaining a copy ofttne
 
 work order with a computer generated number.. 
 26 Itis the responsibility of the Maimtemance Manager and/or the Fauility Manager to
 ensure alll work orders are processed quickly and accurately. 
 
 377 Itis the responsibility of the Maintenance Manager and/or the Fanility Manager to
 immediately and completely repair and render safe alll reported equipment
 malfumetionss. 
 2&8 The Maintenance Manager and/or Faaility Manager must communicate the status of alll
 
 high priority repairs to all affected department Heads. 
 
 4.0 Definitions 
 A 1 QE = Quality Control 
 
 5.0 Referemnes 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev a 
 IMB Ribbon Blenders B-313 2 age 2 0 
 
 5.1 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment.
 
 5.2 SOP G-104 Lockout Tag out Procedure. 
 
 5.3. SOP G-105 Lockout Tag out Devices 
 
 5.4 SOP G-107 Confined Space Entry Program 
 6.0 Procedure 
 
 6.1 Start up 
 6.1.1 Verify the Ribbon Blender operation by running the blender for 30sec, listening
 
 for sounds that are outside the normal functions. 
 
 6.1.2 Check the switches in the electrical panel. 
 
 6.1.3. Check the latches on the Ribbon Blender. 
 6.1.4 Verify that the de-duster is powered on and working properly.
 
 6.1.5 Verify that the proper clean has been performed and signed off in the cleaning
 
 log. 
 
 6.1.6 Check the accuracy of the floor scale and record information in batch record.
 6.1.7. Verify that the appropriate amount of materials has been weighed and pre-
 
 staged to blend the current batch. 
 
 6.2 Loading the Ribbon Blender 
 6.2.1 Verify that the main lid is closed. If the lid to the Ribbon Blender is open call
 
 maintenance in order to close the lid. 
 
 6.2.2 Load the blender following steps listed in the batch record.
 6.2.3. Place the pallet with raw materials to the loading platform using the elevator.
 
 6.2.4 In the event the elevator is inoperable for any reason, this must be reported
 
 immediately and DO NOT use the elevator until it has been fully repaired..
 
 6.2.4.1 A forklift may be used to lift the raw materials to the platform level for
 loading into the blender. Level the raw materials on the pallet as to not
 hit the ceiling. 
 Note: All members of the blending department and QC personnel will be required to
 
 wear a safety harness during cleaning and verifying blender cleanliness.
 6.2.5 Carefully climb the stairs to reach the loading platform. 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 IMB Ribbon Blenders B-313 2 Page 3 of 4 
 
 Note: All employees who are on the loading platform must be trained how to correctly
 attach the safety harness and how to properly attach safety harness to the “D”
 Rings. 
 
 6.2.6 Open the loading hatch. 
 
 6.2.7 Load material according to the batch record. 
 
 6.2.8 If another pallet is needed to load raw material repeat steps 6.2.1- 6.2.3. until
 
 Ribbon Blender is completely loaded. 
 6.3 Discharge of the blend 
 
 6.3.1 Place prepared drums or super sacks underneath the chute for material drop.
 
 6.3.2 Three operators are needed to drop material from the Ribbon Blender.
 
 6.3.3 One operator is responsible for the switch that operates the chute’s open and
 close switch. 
 
 Two operators are responsible for moving drums or super sacks into and out of
6.3.4 position in order to start the process of dropping materials.

 Note: Under NO circumstance should the operators need to reach into the chute or use
 anything to reach into the Ribbon Blender’s chute. Reaching into the chute can
 lead to serious personal injury. 
 
 6.3.5 Repeat filling the drums or super sacks until blender is emptied.
 
 6.3.6 Weigh material according to the batch record requirements. 
 
 6.3.7 Return all unused product to the warehouse. 
 
 6.3.8 Once all drums are weighed and properly tagged, begin the appropriate clean.
 
 7.0 Cleaning 
 
 7.1 Remove all product and paperwork from the previous batch. 
 
 7.2 Verify that the blender’s power supply has been locked out at the disconnect per SOP
 G104 and G-105. 
 
 7.3 Attach safety harness. All members of the blending department and QC personnel will
 be required to wear a safety harness when cleaning/verifying the cleaning of Ribbon
 Blender. 
 
 7.4 Blending rooms identified to have a confined space hazards will be designated and
 follow all of the guidelines prescribed in SOP G-107 Confined Space Entry Program.
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 IMB Ribbon Blenders B-313 2 Page 4 of4 
 
 7.4.1 All entrants working in Confined Space Entry “permit required” conditions must
 be trained and certified. 
 
 7.5 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment to
 
 follow the cleaning procedure applicable to this type of equipment.
 7.6 When cleaning the ground floor of the elevators the Supervisor only must take these
 
 steps to render the elevator safe: 
 
 7.6.1 The Supervisor must raise the elevator to the top floor and engage the E-stop
 button rendering it locked in place. 
 
 7.6.2 The Supervisor must isolate and render the disconnect inoperable by dropping
 the handle to off and Lockout the disconnect. 
 
 7.6.3 The Supervisor must then manually release the door magnet allowing door to
 open and the ground floor to be cleaned. 
 
 7.6.4 When the cleaning complete and quality has signed off, the Supervisor must
 ensure the elevator is completely clear, close the door engaging the magnet,
 activate the Start button, remove the lock from the power source, and raise the
 handle re-energizing the equipment. 
 
 7.7 Only after all of these steps are taken by the Supervisor, may operators continue to use
 the elevators in any room. 
 
 7.8 Document cleaning in the cleaning logbook. 
 
 7.9 Contact a QC inspector to verify equipment cleanliness and to check the cleaning
 logbook. 
 
 8.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 10/13/16 | New \ 01/28/19 Remove reference to 200R. Revise section 7.0. Remove unneeded 19-0101 K. Burris references. | 16-0928 | P. Perry |
| 7 | 05/19/20 | ee guidelines added for inoperable elevator. LOTO Policy CC- | 20-0360 | K. Patton |