Dear colleagues
I need some Guidance and help, please
Do you need to validate the cleaning procedures for a tablet blister packaging machine ???
The machine is cleaned manually.
Does anybody have experience from this kind of operation. Your help is highly appreciated.
Thank You
Dear me_av,
Any part of the equipment of a manufacturing-packaging line that comes into contact with your product needs to be validated with respect to the cleaning procedure followed in terms of Cleaning Validation.
Blistering equipment in deed has to be included in your Cleaning Validation schedule.
Feel free to ask if there are any questions but provide more information for the line and cleaning process.
Best regards,
[quote=me_av@hotmail.com]Dear colleagues
I need some Guidance and help, please
Do you need to validate the cleaning procedures for a tablet blister packaging machine ???
The machine is cleaned manually.
Does anybody have experience from this kind of operation. Your help is highly appreciated.
Thank You[/quote]
Dear friend,
Yeah cleaning validation study must be perform on blistering machine because in blistering where the tablets feed there is more probablity of breakage of tablet which may cause cross contamination, when i conduct clv on blistering mahine i found ample traces of previous product, So don’t neglect blistering in CLV.
Thanks
Dear friends
Thank you very much for your help and your quick response.
The thing is that validation is very new to me. I work as a QP in a little factory and we produce natural drugs, but in Sweden they’re considered as pharmaceutical drugs and therefore has to follow GMP.
I have pharmaceutical background and my work as the QP, but haven’t work for the industry before so the only theoretical study about validations is from the university and after couple of years you loose that knowledge if you don’t use it. So you may say that I ‘m very new at this.
We have validated the production process but the cleaning process is a little bit more difficult.
Can somebody guide me what to do?
So far I have identified the areas to be studied but the thing is where and how to start. Do I start to establish a study protocol or???
As you can see I need a lot of help. So I am grateful for all the help I can get.
Thank you again
[quote=me_av@hotmail.com]Dear friends
Thank you very much for your help and your quick response.
The thing is that validation is very new to me. I work as a QP in a little factory and we produce natural drugs, but in Sweden they’re considered as pharmaceutical drugs and therefore has to follow GMP.
I have pharmaceutical background and my work as the QP, but haven’t work for the industry before so the only theoretical study about validations is from the university and after couple of years you loose that knowledge if you don’t use it. So you may say that I ‘m very new at this.
We have validated the production process but the cleaning process is a little bit more difficult.
Can somebody guide me what to do?
So far I have identified the areas to be studied but the thing is where and how to start. Do I start to establish a study protocol or???
As you can see I need a lot of help. So I am grateful for all the help I can get.
Thank you again[/quote]
Dear me_av,
Is there a cleaning Process for the blistering equipment? This process is the one that you will have to validate.
If there is an established cleaning process, then you need the following in order to proceed with your cleaning validation:
What we usually do is consider for the cleaning validation study the whole manufacturing - packaging line (i.e. mixer, mill, sieves, slugging equipment (if needed), compression machine and blistering equipment. The total surface area is used for the calculations of the Maximum Allowable residue. This MAR is used as Acceptance Criterion for all the swabs samples you are going to take.
The reason you need The Validation of the Analytical Method is because you will have to prove that the method to be used for the assay of the selected API of the worst case product (this is the concept used in CV) can be reliable at levels of 10 ppm or lower than that depending on your calculations.
The recovery factor is also needed so that to make sure that the result you get by each swab is corrected accordingly.
Finally the CV study needs also to be performed for the rinse sample of the equipments.
Some other studies we perform are the Bio Control for swabs (max 10cfu/swab) and rinse sample (max 10cfu/ml) plus the analysis of the water used for the cleaning process to ensure its conformance to Pharmacopoea.
Cleaning Validation is a huge concept which cannot be analysed in just a few lines.
If you be more precise I could be of more help to you.
Please do not hesitate to contact me again.
Best regards,
Dear Sir
I will try to explain the procedure (with my “good”English).
We have established detailed SOP:s for the cleaning procedures and the staff is trained.
The blistering machine was purchased a year ago. . The surface area (stainless steel) that comes in contact with our tablets (film coated) are
The bowl feeder (stainless steel)
The product feeding zone (stainless steel)
Brush box (two, 40 cm long brushes, PVC material.
Basically what we do is:
I was thinking to check the product contact area:
Visually “black “ light
TOC
Microbiological (the problem is do I send the whole brush to the laboratory or ….what)
Product recovery. I don’t know how to do this, maybe use a worse case scenario and compare???
I hope you have a better picture now, if not please feel free to ask and I will try to explain.
Thank You
P.S I don’t know how to atach a file to this message. I will try again
Atachment to the previous message
<img src=/uploads/db7093/original/1X/933f8319d2d850d993d8b7c94203076f6527033a.jpg">
[quote=me_av@hotmail.com]Dear Sir
I will try to explain the procedure (with my “good”English).
We have established detailed SOP:s for the cleaning procedures and the staff is trained.
The blistering machine was purchased a year ago. . The surface area (stainless steel) that comes in contact with our tablets (film coated) are
The bowl feeder (stainless steel)
The product feeding zone (stainless steel)
Brush box (two, 40 cm long brushes, PVC material.
Basically what we do is:
I was thinking to check the product contact area:
Visually “black “ light
TOC
Microbiological (the problem is do I send the whole brush to the laboratory or ….what)
Product recovery. I don’t know how to do this, maybe use a worse case scenario and compare???
I hope you have a better picture now, if not please feel free to ask and I will try to explain.
Thank You
P.S I don’t know how to atach a file to this message. I will try again[/quote]
Dear me_av,
I think most of my response before apply to your inquiries. I would suggest to have a better look on my previous proposals and you shall see the concept that should be applied in my opinion.
Regarding TOC of course is a parameter you should check and UV light as well.
For bio testing you are asking: [COLOR=“Blue”]The areas selected for inspection and sampled (standard size 25 cm2/swab) using a sterile swab should be saturated with Purified Water .
Whatever microorganisms have been caught should be then extracted from the swab in sterile diluent, TMC is determined via membrane filtration.[/color]
The worst case senario involves all your tablets passing through the tableting manufacturing and packaging equipment. Which product shall you select to evaluate your cleaning process? You should be based on:
API concetration/ Potency-Toxicity (LD50)/Solubility of API and possible experience in difficulties that may have occured during cleaning of specific product.
Kind regards,
Dear Gigastorm
Thank you very much for all your help. I will summarize your answers and probably I will ask some more questions, if it is ok with you.
The API of our product is very difficult to determine because we manufacture herbal drugs which there are not always “data” in regards to toxicity /solubility.
P.S. Are there any literature or other documents that you know and recommend to read in regards to cleaning validation for this kind of equipment.
Kind regards
Dear me_av,
Recovery is meant to say that while swabbing the swab which you use may not be capable of removing the actual amount present on the surface of sampling area. Thus recovery studies are carried out so that the same amount of solvent is used for swabbing the known concentration of spiked area which resembles your actual equipment part. If you are able to detect only q% after swabbing out of known concentration then the value of 100-q% gives ur recovery facotr that is y%
For example when you swab and analysed the sample on the equipment part you may get value of x but the value may not be the same as it is on the equipment so a correction factor is to be included so that basing on our recovery study you say that it is x + xy% is your actual concentration present on that equipment at that place.
hope this clarifies about recovery.
there are numerous articles regarding this just google with “cleaning validation” or the respective area wher you are not clear.
dear
following points must covered…for CV of blister pkg.m/c.
it must come in equipment train ,three consecutive runs must be conducted for successful CV.
swab must taken from these points in Blister Pkg.m/c.
1.chute
2.hopper.
3.guiding track.
Also micro samples must be taken along with chemical analysis for showing absence of microbial contamination.
regards
prasad
QUOTE=Gigastorm;1705]Dear me_av,
Any part of the equipment of a manufacturing-packaging line that comes into contact with your product needs to be validated with respect to the cleaning procedure followed in terms of Cleaning Validation.
Blistering equipment in deed has to be included in your Cleaning Validation schedule.
Feel free to ask if there are any questions but provide more information for the line and cleaning process.
Best regards,[/quote]
If you do not have data on solubility/ toxicity, you should at least consider the potency of the drug. The most potent drug should be considered as worst case. If you have data of potency then its not needed to do by considering the toxicity. Toxicity is not required if the dose of the product is available. Consider the dose of the product. Regarding solubility you can test yourself at your lab by dissolving the drugs at solvent and consider the amount of solvent required for dissolving the drug. The more amount of solvent is required, the more worst case for solubility will be your drug.
[quote=me_av@hotmail.com]Dear Gigastorm
Thank you very much for all your help. I will summarize your answers and probably I will ask some more questions, if it is ok with you.
The API of our product is very difficult to determine because we manufacture herbal drugs which there are not always “data” in regards to toxicity /solubility.
P.S. Are there any literature or other documents that you know and recommend to read in regards to cleaning validation for this kind of equipment.
Kind regards[/quote]