B-312

V-Blenders

Section B — Manufacturing Revision 4 4 pages

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

Standard Operating Procedure SOP Number Revision
B-312 4
{ey Lap:
V-Blenders
Effective Date Page
os Y4 bu Page | of 4
isty Reviewed By/Date Agpiowed By/Dhte
ng T { A i d oe fc ? ," BZ ' Frat ayé:/ro mL OYte, hy,An A. obyla So
| Title: EH&S Manager Title: Blending Supetisor Titile: fireger °

ilaO Punpose

This procedure defimes the process for the setup, operation, and cleaning ofttme 6, 40, 50. and
100 cubic foot v-blemders.
200 Scope

This procedure applies to the 6, 40, 50, and 100 cubic foot v-blemders in operation at lon Labs,
Inc.
800 Regpons loility

811 Itis the responsibility ofall production (blending) personnel to follow this procedure.

222 Itis the responsibility of the department supervisor/manager to implement this
procedure and to ensure that the procedure is being followed.
233 itis the responsibility of alll operators to immediately report any equipment which is

malfunctionimg or not workiimg to the department supervisor.
S414 Itis the responsibility of all department Supervisors to immediately report any
equipment malfunctioning, not workimg, or any safety consem to the EHS Manager,
Maimemance and the Facilities Manager for an operational disposition.

855 Itis the responsibility ofttne supervisor to create a work order, clearly and spazifically
document the level ofpriority and ensure a system generated Work Order has been
suocessdiuilly entered by obtaining a copy of the work order with a computer generated
number specific to that work order.
&6 itis the responsibility of the Maiimtemamee Manager and/or the Faaility Manager to
ensure alll work orders are processed quickly, accurately and fully.

877 Itis the responstiility of the Maimtemamee Manager and/or the Facility Manager to
immediately and completely repair and render safe all reported malfunctiomimg or not
working, equipment.
888 The Maimtemance Manager and/or Facility Manager must communicate the status of all

high priority repairs to alll affected department Heads.
AoO Definitions

411 IPA = 70% Isopropyl Alcohol
422 BPR = Batch Productiom Record

433 @E = Quality Control
500 Refersmass

511 B-103, SOP, Smaill Parts Cleaning and General Samitation

CONFIDENTIAL; For ION Labs use only

[SOP

Standard Operating Procedure SOP No Rev
V-Bibm ders B-312 4 Page 2 of 4

fo2 BI 1, SOP, Cleaning of Manufacturing/Productiom Areas and Equipment
£33 SOP G-104 Lockout Tag out Procedure

514 sop G-105 Lockout Tag out Devices

600 Procedure
61.1 Setup

6.1, i Inspect and verify that the room and equipment have been properly cleaned and
the cleaning log has been signed from the previous batch by a Q€ inspector.
61122 Obtain the BPR from the Q€ area. Using the BPR, enter the product name and

batch number in the cleaning logbooks.
61133 Initial and date alll entries. Call a @€ inspector for approval.
&22 Operation

Notte: The 6cu v-blender and 40cu v-blender have intensifier bars that will be used as
specified in the BPR. Refer to the weigh amd mix order for instructions on
intensifier bar usage.

62211 Bring the previously weighed, screened, or milled raw materials into the room.
62222 Use the drum lifter, ladder, Vac U Max or manuallly load the raw materials into
the blender, following the order specified in the BPR.

6222.1 Before loading the raw material into the blender located in Blending
Room B-2, moumt amd seoure the stainless stex| food grade funnel
between the mezzanine rail and the blender opening.
6222.2 Pour the raw materials into the blender using the funnel.

6222433 Never step over railing omto blender frame. Breactning the platform
and/or the safety railing for amy reasom willl result in discipline up to
terminatiom.
6222244 In the event the drum lift or elevator is inoperable for amy reason, this

must be reported immediately.
6.22244.1 Immediately Lock out and Tag out per SOP G-104 and G-
105 any dinwm litt or elevattor which is mot operating
properly.
6.2242 A fatkliit may be usati to lift the raw matenials to the

platform level for loading into the blender.
6222443 When in Blending room 2 use the funnel attachment to pour
raw materials into blender.

62233 When all raw materials have been properly loaded into the blender, secure the
lids.

Note: Prior to the “ON” and “OFF operatiion of the blender, the operator(s)
must attach the safety banicade that will not allow operator entrance past
the yellow caution marking identified on the floor while the equipment is

[SOP

Standard Operating, Procedure SOP No | Rev Figas § afd |
V-Blenders B-312 nl cel

in operation.
Negtg: All associates must adhere to the safety barricade, caution markings, and
door cautions while equipment is in operation.

63311 Pull down the lever on the power box to the OFF position.
63222 Prepare the proper number ofclzan contaimarss.

63333 Line the containers with clean plastic bags.
630314 Place the prepare comtaimer under the outlet valve. Seoume the plastic bag
around the outlet valve.

62377 Close the bag by placing a seal on the bag.
63388 Prepare an in-process label and secure it to the outside oftthe container.

63229 Repeat steps 6.3.3 through 6.3.8 until the blend has been completely discharged.
6.3.10 lif excess powdlar is present in the blender, scoop it out amd place it into a

container.
614 Cleaning,

641.1 Remove alll materials and paperwork from the previous batch.
6422 Fallow SOPs B-103 Small Parts Cleaning amd) Gemaradl Sanitation amd B-111
Clearing of' Manufactwitng!Prodruction Areas anti Equipment to follow the
cleaning procedure applicable to this type of equipment.
635 When cleaning the ground floor of the elevators the Superwisor only must take these

steps to render the elevator safe:

6511 The Supervisor must raise the elevator to the top floor amd engage the E-stop
button rendering it locked in place.

6222 The Supervisor must isolate amd render the discomect inoperable by dropping
the handie to off and Lockout the disconnect.

6533 The Supervisor must them mamuallly release the door magnet allowing door to
open and the ground floor to be cleaned.

644 When the cleaming complete amd quidlity has signed off, the Supervisor must
ensure the elevator is compleisly clear, close the door engagimg the magnet,
activate the Start button, remove the lock from the power source, and raise the
handie re-energizimg, the equipment.

[SOP

Standard
V
O
.
pe
t
r
i
at
e
in
a
g
d ee
P rocedure SBO-P3 1N2o | Re4 v Page 4 of 4
666 Only after alll of these steps are taken by the Supervisor, may operators contimue to use
the elevators in any room.
(611 Document cleaning in the cleaning logbook.
6(Q22 Contact a QE inspector to verify equipment and room cleanlimess amd check the
cleaning logbook.
790
Revision History
Revision Date Desaription of Changes CCR # By
0 07/28114 | New 4-042 S. Kovalik
| 03/30/15 | Added notes in section 6.2.3. 15-0297 K. Burris
2 06/23 t5 | Revised to include alll v-blemdirss. t5-0549 EE. Cunniringss
3 o1/osv1g | Soremuled review. removed Obsolete definoms. Added reference | 19.0029 K. Burris
4 05120120 | Safety Guidelliress and use offtumnel added CEA OBE K. Patton