Dispensing of packing materials


(MADHUSUDHAN) #1

FOR DISPENSING OF PACKING MATERIALS DO WE NEED SEPERATE DISPENSING BOOTH i.e
RLAF/LAF .CAN WE CARRY OUT THE ACTIVITY IN THE RAW MATERIALS DISPENSING BOOTH ITSELF . DOES ANY GUIDELINE SPEAKS ABOUT THIS.

PL.CLARIFY


(Madeeha batool) #2

Specify the packing material…


(Dinesh Kumar Shukla) #3

if primary packing dispensed in loose quantity or open pack then required RLAF other than full intake pack dispensed not required RLAF


(dushyant) #4

DISPENSING OF PACKING MATERIALS CAN BE DONE WITH OR WITHOUT USAGE OF RALF. THAT ALL DEPEND UPON TYPE & CRITICALITY OF PACKAGING MATERIAL.

For Primary packaging material
Primary pack available as follows for dispensing stage.
Type 1. Intake pack i.e. Desiccant pack, ready to use rubber stopper( Pre-sterlize)
2. Intake pack but we can dispense as loose by using RALF with proper environmental condition.
3. Routine pack with Single/double poly bag which further pack in tertiary packaging material from vendor.
Type 1 material no need to dispensing in RALF, we can directly transfer to user department.
Type 2 material we can use RALF for dispensing activity.
Type 3 material we can directly transfer to user department but make sure your IH SOP allows to do so

Secondary & tertiary packaging material
We can dispense the Secondary & tertiary packaging material to user without using RALF.


(Tek Chand Sharma) #5

Yes, separate booth should be there to perform the PPM sampling as well as dispensing. Below is the more detail w.r.t. PPM material dispensing:

For PPM Issuance
-For Vials/ampoules shall be issued only as intact inner pack quantities from the manufacturer. No partial quantities can be issued.

-Ready to use (RTU) and ready to sterilize (RS) rubber stopper shall be issued only as intact inner pack quantities from the manufacturer. No partial quantities can be issued.

-Other rubber stoppers shall be issued as intact inner pack quantities from the manufacturer, with any additional loose quantities to be issued either by count method or weight method.

-GAMMA irradiated seals shall be issued only as intact inner pack quantities from the manufacturer. No partial quantities can be issued.

-Non-sterilized aluminum seals shall be issued as intact inner pack quantities from the manufacturer, with any additional loose quantities to be issued either by count method or weight method.

Normally if material is non sterile then we can open the same in the sores, but if PPM is sterile then we have to issue the same as intact.

Hope this will help you!
Thank You!


(dushyant) #6

Thanks for updating info.of Injectable grade primary PM. Moreover we shall evaluate scientifically for using the RLAF/LAF primary PM other then injectable.


(Dhiraj Prasad) #7

No, we can 't used the raw materials dispensing for the dispensing of packing materials. To avoid the contamination we must used the separate the dispensing booth for dispensing of packing materials.