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IgCP Exam - Ig Products - Storage & Handling Questions and Answers Already Passed

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IgCP Exam - Ig Products - Storage & Handling Questions and Answers Already Passed How should Ig be stored? - Answers * Depends on Product - Temps listed in PI for optimal stability * Liquid Products - either room temp or refrigerated * Some individual products can be: *refrigerated for max stability = longer shelf life OR *stored at room temp = shorter shelf life Refrigerated temp is? - Answers 2-8° C 36-46° F Room Temp is? - Answers ≤ 25° C ≤ 77° F What should be done if the Ig Product is Frozen? - Answers Discard if frozen How often should temp of stored product occur? - Answers Daily and recorded Can you contact Manufacturer if product is stored outside the temp range for short period of time? - Answers Yes Whether to utilize s/b outlined in company P&Ps How should products that come refrigerated, but have limited room temp stability - Answers * Only be brought to room temp within PI parameters Example #1 - One product can be store for 36 months refrigerated and only 9 months room temp, BUT it must ONLY be stored at room temp if it is within the first 24 months of manufacture (or 12 months before the exp date) Example #2 - One product can be brought to room temp for 6 months anytime with its refrigerated stability period, BUT if brought to room temp 3 months before its exp date, the product would still expire on its refrigerated exp date Should Ig be refrigerated again after bringing to room temp? - Answers NO What determines stability if an Ig product is pooled? - Answers * USP 797 Who can pool the Ig Product? - Answers * Pharmacy - aseptically in the hood BUD follows USP 797 * RN in the home and would fall under USP 797 Immediate Use and Administration must begin within 1 hour and must be Continuous Once Ig product is warmed to room temp, it should be used within 24 hrs or according to company policies, procedures and manufacturing guidelines - Answers When should Ig Products be discarded prior to infusing - Answers If the product is turbid, discolored or many particles are present.

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IgCP Exam - Ig Products - Storage & Handling Questions and Answers Already Passed

How should Ig be stored? - Answers * Depends on Product - Temps listed in PI for optimal

stability



* Liquid Products - either room temp or refrigerated



* Some individual products can be:

*refrigerated for max stability = longer shelf life

OR

*stored at room temp = shorter shelf life

Refrigerated temp is? - Answers 2-8° C

36-46° F

Room Temp is? - Answers ≤ 25° C

≤ 77° F

What should be done if the Ig Product is Frozen? - Answers Discard if frozen

How often should temp of stored product occur? - Answers Daily and recorded

Can you contact Manufacturer if product is stored outside the temp range for short period of
time? - Answers Yes



Whether to utilize s/b outlined in company P&Ps

How should products that come refrigerated, but have limited room temp stability - Answers *
Only be brought to room temp within PI parameters



Example #1 - One product can be store for 36 months

refrigerated and only 9 months room temp, BUT it

must ONLY be stored at room temp if it is within

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