hello everybody,
what is the class for non asceptic oral liq. fac. HVAC?–is it class 100000? are F9 filters in the system sufficient?
[b]There are few new reccomendations floating around the regulatory agencies regarding this subject
The Packing zone and periferal zone will be class 100000
The Manufacturing or Batch preperation will be class 10000
Filling & sealing will be in 10000 followed by Inspection ,labelling and Packing will be in 100000 areas.This operation is cointinuous or online activity from Fill to pack in most of the companies who produce these in large numbers.[/b]
Dear Mr.Durga,
Could you pl post me protocol of prospective hvac validation
K.Manivannan
Senior Manager QA
TTK Healthcare Ltd
Dear Mr. Mannivannan,
I can post it, but I need what HVAC systems and classifications you have.
Please look your in box in this site.
I will ask some questions.
Regards
Dear Mr Durga,
Is there any guidelines which specifies that the classification of air quality for liquid oral manufacturing facility.( other than the floating recommendations)
Secondly during packing, there could be lot of particulate generation and will it be possible to achieve the class 100000 area?? .
I have been following your comments very vividly and find quite informative and knowledgable.
Thanks
Rajan Moily
India
Honestly speaking most of the guidelines only interpret about Aseptic facilities and Oral dosages. We have to take care few aspects of the formulations of oral dosages into consideration like type of dosage, materials used (Solids/oils/ liquids), exposure and packing considerations, cleaning considerations, use of materials like sugar where there is potential hazard for fungal or bacterial growth if they are not properly cleaned on or inside equipments or spillages on floors.Water considerations of a plant.
Me and Mr.Graham are closley working in bringing out specific file on considerations of GMP in oral dosages with 3 sections like Tablets-capsules, Liquid orals and final section with Reconstituted Oral dry powders.
Many aspects are involved in these like Design, Flow of men and materials, flow of air, Dust collectors, Operators saftey from API,s, Management of records, Packing, Dispensing, Weighing , Operations etc.
I would request all to ask specific questions that you encounter at your facility. We can really tharsh them down as discussions at our end and give you all solutions that complies with GMP.
Regards
Particle generation in packing is most common issue in liquid orals. The problem is that it involves Inner cartons and leaflets at phase 1 and then shippers at phase 2.
Typically all these are cellulose materials. They can generate huge particles and heaven for bioburden.
There are few things that companies should take care to reduce particle generation. It might come with some expense.
- Always de-dust in a specific room by gentle vaccum cleaning of all cartons just after request for materials is issued. Some might as why should it be de dusted second time? The reason is simple : There is a gum in between the plys of the shippers. It will dry out and it might lead to potential particulates in air and potential bioburden source. Please make a SOP and make sure people read and do it as per procedures layed down at ur site.
2.Most of times avoid sticking lables with Accacia gums on shippers either in your Corridor or in your packing room. This is a potential bioburden and particle generating practice. Educate your fellow collegues and workers and enlighten your management to use Stickers (Note: We are not promoting any sticker manufacturing industry here.We are considering potential fall outs).
- Never pile up the shippers folded at ur packing area. Then suddenly when the bottles pile up some one will run and open those cartons into shape and start sticking lables. Instead bring the dedusted cartons, open them into proper shape and keep them at proper place 10 to 15 minits before the bottles actually come on to the packing conveyer. Same applies to inner cartons too. Make sure that your QA PROFESSIONAL gives line clearance at relatively good time and infront of him you open and keep it ready and throw out as much as possible of the particulate air out of your circulation.
4.Never bring any gum powder and mix with water in packing areas. This is biggest blunder sometimes done during peak packing schedules. Avoid this procedure.
QA and Production team should have proper co-ordination, logic and understanding to bring such procedures into implmentation.
Regards
we are constructing a new tablets and liquid oral formulation sections Pl post me the validation guidelines for this project
Regards,
K.Manivannan
Dear Mr. Durga Prasad,
Can you please tell the temperature and RH Requirement of Oral Liquid Facility and also for Eye Drop manufacturing Facility?
Liquid Orals : The ideal requirement would be between 45-50% RH and Temperature 23 to 25C
Eye drops: 45% RH and Temperature 20-22C (in core areas of compounding, filling and Labelling)
If you have temeperature sensitive products you need to adjust for those specific products.
Since in both casses you do not have any hygroscopic compounds you need not lower the RH. Lowering RH might probably leads to slight evapouration of liquid products.
Dear Mr,Durga,
Briefly outline various types of hvac systems for solid and liquid dosage forms
Regards,
K.Manivannan
Mr.Manivannan,
I did not understand your question.
Do you need design aspects or any other thing–Please write it clearly.
Regards
i found the articles useful. i wish to get assistance for HVAC validation protocol. if possible do send me in my inbox