Solid Coating Pan

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1.0 Purpose 
 The purpose of this procedure is to outline the process for the operatiion and cleaming of the
 solid coating pan utilizimg volatile solvent film coatimgss. 
 PaO Scope 
 This procedure applies to alll solid “candy” coating pans in operation at lon Labs, Inc:
 3.0 Regponstbliity 
 311 Itis the responsibility of production (coating) personnel to follow this procedure.
 222 Itis the regponsibility of the department supervisor to implement this procedure and
 ensure that the procedure is followed. 
 4.0 Definitions 
 Ai] IPA-T0¥Aseppapyil Alcohol 
 422 DI Water = Deionized Water 
 433 QE = Quality Control 
 Aa 4 Minor Clean ~ A cleam betweem batches of the same product (refer to SOP B-111
 Cleaning of Manufacturing/Productiom Areas and Equipment) 
 455 Major Cleam - A clean betweem batches of different products or before long-term
 storaye (refer tO SOP Blil Cleaning Of Manufacturing IPrebtivttion Areas and
 Equipment) 
 5.0 Referemcess 
 51.1 C-104-F7, Form, Coating Record 
 2 B-1114Fl, Fonm, Cleaning of Manufacturing/Productiom Areas and Equipment
 5:3 B-103, Form, Small Parts Cleaning and General Samitatiom 
 6.0 Procedure 
 611 Operation 
 6.4.11 Bring, tablet cores into coating room. 
 61122 Ensure alll coatiixg materials are in the room and have not expired.
 61133 Open the coating pan door and load the tablet cores into the pan.
 CONAIDENTIAL: For ION Labs use only 

[SOP 

 Standard Operating Procedure | SOP No Re f v Page 2 of3 | 
 Solid Coating Pan B-703 
 
 61144 Start the coaiimg pan by adjusting the speet control. The optinnadl speat is
 dependent on pan charge and prodwwes a smooth cascade. 
 
 Note: Softer tablet cores are best tumbled at lower speeds. 
 61155 Adjust the air inlet and vacuum controls then briefly close the door to remove
 any residual dust. 
 
 61166 Measure the coating solution, tipically 300-500mi for a 24" pan. Optimal
 coating volume per pam is depemdemt om operatior's discretion amd experience
 with the specific product being coating. 
 61/77 Temporarily turn off the air inlet, open the door, amd slowly amd consistently
 pour the coatiing solution back and forth across the tablet bed until alll coating
 
 solution has been applied to the tablet cores. 
 61188 Tum on the air inlet and close the door, allowing tablet cores to tumble. Adjust
 pan speed as required. 
 
 61199 Rum the coating pam for 5-20min, occasionally checking the tablets for cured
 coating. Coating time per pan is at the operator’s discretion and experience with
 the spauific product being coated. 
 6.11.10 Once the tablet cores have been coated tum offttne inlet air.
 
 6.1.1 11 Open the coating pan door amd with the pan siill rotating apply a small amount
 of talc to the tablet cores to prevent sticking. 
 6.11.12 Utilize a clean scoop to empty the coating pan. If the tablet cores are known to
 be soft stop the coating pan to empty it. If the tablet cores are sufificiently
 durable the pam speed may be reduced to a minimum and the tumbling action
 utilized! to aid in soooping the tablets out. 
 
 6.1.18 Once all tablet cores in the batch have been coated compiete the coating yield.
 6.11.14 If amy comments may be made about the coated tablet cores, e.g. high instance
 of breakage, record them i the comments sacttion at the bottom of form
 
 C-104-F7. 
 6.11.15 Initial and date form C-104-F7.. 
 
 6.11.16 Remove the coated tablets fiom the coating room and labell them quarantine
 pending QE release. 
 &22 Cleaning Procedure 
 
 6211 Remove all product and paperwork from the previous batch. 
 6222 Refer to SOP B-111 Cleaning of Manufacturing/Productiom Areas and Equipment
 to follow the cleaning procedure applicable to this type of equipment.
 
 62233 Document cleaning in the cleaning logbook. 
 62244 Contact a QE inspector to verify equipment cleanlimess and to check the cleaning
 logbook. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev ‘ign § ok 
 Soli. d Coati. ng Pan B-. 703 4 a8ge 5 0 
 
 700 Revision History 
 
 Revision Date Description of Changes CCR # By 
 0 08/20/10 | New - - 
 I 03/17/11 | Made some minor changes - - 
 2 OB22Q0t2 | Changed SOP title. Made SOP more detailed. t2- 105 M. Wienke
 
 = 4 aati _ | c U o s a p t d e a r t e a d n d fo n r o m t at a . c t C h as a n a g g e e d n e t r i a tl l e , c R o e a w t r i o n t g i p e r t o o c e p d e u r r t e a . i n to only the 24° L607 C. FAymon
 
 4 03(26(20 | Revised and updated for cleaning procedune 6€C2002 13 | E. Hubbell