Air Changes and Product Data Analysis uses in Pharmaceuticals is the use and application of data analytics in the pharmaceutical industry. Integrating big data analytics solutions into pharmaceutical manufacturing processes allows companies to gain valuable insights to accelerate and optimize production.
Standard operating procedure Air Changes and Product Data Analysis to measure the air velocity and air changes per hour in CFM in classified area. The measured air quantity shall not be less than the designed air quantity and the calculated air changes shall not be less than the designed air changes per hour.
Objective :-
To ensure the air changes in sterile areas (clean Room) as per specification and To analyses product related data for conformance to specifications, determine trends & to take appropriate actions for improvement.
Scope:-
Product & process quality evaluation at pharma Plant by using suitable statistical techniques. Air Changes and Product Data Analysis It is applicable to the following areas:
- Liquid Vial Injectabl filling area
- Liquid Ampoule Injectable area
Responsibility:-
- QA Manager / Incharge
- QA Officer
- HVAC Engineer
- Plant Manager
- Quality Control Manager
- Quality Assurance Manager
- QC Officer
Procedure:-
In clean rooms, where Injectables are manufactured, it is necessary to periodically monitor the condition of the room. This is done by Air Changes and Product Data Analysis periodically measuring the velocity of the HEPA filtered air sent into the room and calculating the air changes in the room. This is an important parameter to assess the purging capacity of the air handling system. With the help of Anemometer the velocity of the air is measured at different sites of HEPA Filter out let and from this data the numbers of air changes are calculated.
Air Changes and Product Data Analysis
Calculation for number of Air changes in Sterile Area
a) Number of Air inlets in the room = “N”
b) Area of the inlet surface = Length X Width = “B” square feet
c) Average Velocity of Air through an inlet = “C” Feet/min
d) Volume of air = Area of surface X Average Velocity through an air inlet
i.e. = “BX C” Cubic feet / min
Let “BX C” be denoted by “D”
e) Volume of the room under consideration = L x W x H = E Cubic feet.
Now number of cubic feet of air through all filters / min = sum of cubic feet / min, of air through each filter in the room.
Thus CFM = D1 + D2 + D3 ………….. DN-1 + DN
Total CFM Di denoted by “F”
i = 1
f) Total Cu. Ft of air through all filters in 1 hour = F X 60 CFH (where CFH = Cubic ft / hour)
Now 1 air changes = Total Volume of Room = E. eu.Ft.
Thus E Cu. Ft / Hour corresponds to 1 air change.
F * 60 Cu. Ft / hour corresponds to Air Change =
F * 60 Cu. Ft / Hour = Z air change
E Cu. Ft / Hour
Criteria:-
Air changes / min (Z) should not be less than 20 for Class 10,000 and 5 or more for components preparation room.
Check Frequency:-
Calculate the air changes for Class 100 area and component preparation room at quarterly frequency.
Product Data Analysis Procedure:-
The following statistical techniques / tools are being used in the plant.
A) Sampling Plan for Incoming Materials & Products
For the sampling of incoming goods and produced batches American military standard MIL-STD 105 – E is being used to take the representative samples for inspection / testing of raw materials, packaging components and finished products. Acceptance levels are defined on the basis of these plans and reports are generated for each sample and analysis.
B) Trend Analysis
i) In process Inspection Data
Physical parameters of liquid injections, Liquid syrup, Tablets, Capsules and dry powder injections are checked during the operation at predefined frequencies. Results are plotted on pre-printed trend charts (range charts) are provided with upper and lower allowable limits.
Trends are reviewed regularly during the process by production and IPC staff and are finally reviewed by QC Department before final release.
ii) Finished Products (Active Potency data analysis by Line Graph)
Results of active ingredient’s assay are plotted for each batch on graph sheet to analyze the trend of batch wise product quality.
These plotting are reviewed in GMP committee and quality council meetings. The observations are discussed & appropriate corrective and preventive actions are identified for improvement.
C) Variance Analysis:
This statistical technique is applied for the data analysis in
a) Liquid Injectable Volume data in QC Lab.
b) Powder Injectable drug weight data in QC Lab
c) Weight Variation data of OSD (Tablets & Capsules) forms in QC Lab.
d) Liquid Syrup Volume data in QC Lab
e) Analytical method validation in QC Lab.
f) Process Validation in Production
Standard deviations calculated to establish consistency of the relevant process / method.