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TECHNICAL PROFILE
The Low Density Polyethylene bag (inner bag) is
filled with the product, put under vacuum, sealed and placed into another bag (middle bag) made of High Density
Polyethylene, put under vacuum. This second bag is placed into another bag made of aluminium bonded with
polyethylene, nylon and polyester. This third bag is put under vacuum and sealed again, so it is completely
air tight.
STERILITY OF EXTERNAL SURFACES - The external
surfaces of the inner LDPE and the middle HDPE bag are sterile and free of particles.
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SAFETY OF INTERNAL SURFACES - During manufacturing,
the internal surfaces of the polyethylene bags , never come in contact with other environment than Grade A;
the innermost bag is opened by the user in a cleanroom under laminar flow, in Grade A area again. In this way,
the risk of contamination of the API (immediate container) is avoided.
STERILITY MONITORING - It is possible to check
each SterBag® for integrity: as long as the bag is under vacuum, sterility is assured. This is immediately ascertained by the operator checking the brick-like
appearance of the bag.
SPACE SAVING AND DISPOSAL - SterBag® is a
disposable single use container and it does not require storage space either in cleanroom or warehouse.
 HOW TO CHECK THE INTEGRITY -
Before using the injectable API contained in SterBag®, , it is necessary to check the integrity of each bag, to
be sure that the sterility of the product has been maintained during shipping. It is a very simple operation:
the operator has to check that the package has a brick-like appearance, and the powder is neither soft nor free-
flowing inside the bag. When the powder is soft in its package, it means that all three bags have lost vacuum,
and the sterility of the powder itself is questionable. The bag should not be used.
The maximum advantages of SterBag® are only achieved if it is properly used. An example of correct approach
to the use of this packaging system is the following:
STERBAG HANDLING PROCEDURE
The sterility of the product contained in SterBag® is guaranteed only if this is correctly opened and entered in the grade A area for filling. To this purpose, we offer in this brochure an acceptable procedure for opening SterBag® without risk of contaminating the product. In case this procedure is not clear or not applicable in your facility, please contact ACS DOBFAR for assistance in establishing alternative procedure.
Operators handling SterBag® should be properly trained.
The correct use of SterBag® should be validated by media fill.
- In the pre-sterile preparation area (Grade D or C) put the SterBag® in the pass-through
box following a validated sterilizing procedure (i.e. hydrogen peroxide).
 
Alternatively, if pass-through box is not available, in the pre-sterile preparation area (Grade D or C) prepare in a
clean container about 50 litre of 1% Peracetic Acid solution (or equivalent validated disinfecting solution).
Immerse each bag in the solution for not less than 30 minutes. More than one bag at a time may be treated.
Be sure that bags are completely drowned.
- Proceeding from inside the cleanroom (grade B area), open the pass-through box door;
using sterile scissors, cut with care the aluminium bag 2 cm from the edge. Strip the bags from the aluminium bag,
leaving it inside the pass-through box (it will be removed from the preparation area).
- Deliver the bag to the Grade A area by appropriate procedure (decontamination or removal
of middle bag) cutting the bag 1 cm from sealing without damaging the internal bag. The internal bag is stripped out
using aseptic procedures.
- The bag is now ready to be opened and used for filling, either using the proposed stainless
steel adaptor, or other equivalent validated procedure.
The inner bag containing the sterile product should never
leave Grade A area until empty. After leaving the Grade A area, any opened bag should be discarded.
(Please, contact ACS Dobfar if a different procedure is to be used)
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