What is the type of nitrogen to be used in manufacturing processes of capsules and sterile products?
Is there any regulation that establishes this type of nitrogen?
Follow below mentioned URL to know the set of parameters required for gases used , I’M doing analysis as per below requirements
https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.eiga.eu/index.php%3FeID%3DdumpFile%26t%3Df%26f%3D3295%26token%3D1d87bcc82d5da58bc1235ad0815312237ea22acd&ved=2ahUKEwifk-LE69TcAhVCKo8KHSwTB_EQFjABegQICxAE&usg=AOvVaw2diWOEMVMgMud_Z577YOWB
Dear Milagrosds,
Purpose Nitrogen Validation shall be carried out in case there is direct contact of the product with the gas, Basically in sterile and some non sterile manufacturing and filling.
Scope:Nitrogen used for providing an inert gas in the vial, ampoule or WFI tanks and used for creating an inert pressure pad in processes where solvents are present.
The Quality of Nitrogen Gas is important to ensure that product is safe.
The validation study includes:
• Dew Point • Oil Content • Particulate matter • Moisture Content • Viable Count.
In addition to that other parameters should also be checked such as:
Nitrogen Gas quality are: • Purity (With reference to supplier certificate)• Gases such as O2, CO & CO2 • Odor Identification Test. (You can take help of outside vendor for Chemical tests)
Test and acceptance Criteria: You can follow, the European and US Pharmacoepia sets quality standards for Nitrogen Gas.
Sampling & Testing: Shall be done by microbiologist dept.
Sampling points shall be : Point of generation and point of use
Study duration :2 Months
Inference: Based on Study you can prepare SOP for Microbiological (Bioburden level) and Chemical Analysis(Moisture, oil and mist presence, Hydrocarbon level) of Nitrogen Gas in Sterile area
Microbiological (Bioburden level) and Chemical Analysis of Nitrogen Gas in non-sterile area (Liquids)
Thank you very much for the information
Thank you very much for the information!
This information comes from a regulation? Could you tell me what it is? Thank you
do microbiological analysis with plates or bubbling? And how often is the frequency of the microbiological analysis? Thank you.