we are facing problem when handling severely photosensitive compound, especially in the sterile solution.after primary packed, the all products should be visually-inspected (100% inspection) under the lamp, that could reduce the concentration of the API. is there any lamp suitable to be used to process this kind of product?
thanks in advance.
Can you visually inspect the product while it is inside an amber bottle? Perhaps you can use a red lamp, or maybe even a UV lamp, because lights at different wavelengths will have a different (or less) effect on the API, but then you may have to run a validation on that specific lamp to see what the effects on the API are. And perhaps that is the answer, validate the inspection procedure to certify it as “no effect on product when exposed to light for ~1 minute.”
Normally as per GMP procedures visual inspection is peformed under a white light having 700 candle intensity on a black and white back grounds.
Amber bottles are meant to prevent light that makes the product degrade.
In your case you can chose a darker amber glass and reduce the light to 500 Candles.
Its a peculiar case that API concentration is effected.I do not think so that visual inpection is causing this problem.
You might have an ingredient which effects it Or There might be a sprcif type of vial that should be used that is not followed (Ignored in routine process).
Please consult your R&D and Technology transfer group and carry out a scale down study in your lab.
What type of rubber bung you are using and what is its absorption rate of that particualr product?
This is an imporatnt aspect of stability. During primary packing and inspection if you lose API its gives a dangerous signals on stability of final product prior to release.
The only solution is consult your technology team and review process of manufacture,specifications of your primary packing materials.
Regards
how do we convert candles to lux unit? we prefer to use lux unit for illumination unit.
for such kind of products we use amber ampoules. it is difficult to inspect and sometime need more time under the lamp than products with clear ampoules.
in the process room, is sodium lamp used at the ceiling? or is there other option to avoid too much light entered the tank?
No Sodium lamps
You need floroscent lamps.
I mean that we could install (low pressure) sodium lamp in our mixing and filling rooms, beside the fluorescent lamps.
in normal condition we use fluorescent lamps. when we need dark condition, we use the sodium lamp since it has very narrow spectrum:
we can compare it with the spectrum of fluorescent lamps:
due to its narrow spectrum, sodium lamp may be safer to our photosensitive products. however, we will see weird image’s color under this lamp.
All the datas and spectrums sound good and look good for educational purposes.What is the wavelength that is causing present product to degrade is important.
If you review my first post I was speaking about technology transfer.
Kindly ask your formulation chemists who have education, Training and experience in formulations–What are their observations during Pilotplant optical inspection process?
What is the wave length they used?
What is the back ground light used?
What is the amber bottle used during the stability data studies during submissions?
What is the maximum quantity of batch that is transferred from Pilot to production? Any batch size variation.
Do they have the Photostability Data?
You need to review all.