Antibiotics are a type of antimicrobial used in the treatment and prevention of bacterial infection. They may either kill or inhibit the growth of bacteria.
Filtration purpose:
Prefilter: remove the particles, colloid, and extend the working life of fine filters followed.
Fine filter: remove the bacteria, mycoplasma.
Filtration criteria:
1. Remove the particles, colloid, bacteria, mycoplasma.
2. Free flow through of main ingredient in the nutrient solution (especially good chemical compatibility.)
3. Stable filtration flow rate.
Filter selection:
| Filtration process | Filter selection |
| Prefilter | GF |
| Vent | IPF |
| Sterile | IPS |
Filtration Process:
LVP is sterile injection liquid into human body by vein, and it volume not less than 50ml.
Main ingredient of LVP:
Water,glucose,amino acid,salt, and viscous nutrient solution.
Now available in the market mainly are four different kind of LVP:
Glucose, NaCl,Glucose/NaCl, Metronidazole
Filtration purpose:
Prefilter: remove the particles, colloid, and extend the working life of fine filters followed.
Fine filter: remove low biological load; sterile filtration
Filtration criteria:
Safety: Filters should be of good mechanical strength, as bottling under high pressure and high speed
Stablity: Filters should provide stable filtration speed and filtration efficiency
Bacterial free: No living bacteria in LVP
Filter System Configurement:
Filtration System Diagram:
Small volume parenterals (SVP) include various traditional and bioengineered drugs. These drugs are usually packaged in small vials (less than 20 ml), pre-filled syringes and ampoules, or made in lyophilized powder. Lots of SVPs need aseptic processing for their lack of heat-stability.
Sterilizing filtration is used after synthesis or before filling. And it can add the sterility assurance if sterilizing filtration is used at both locations. Prefilters should be used to reduce bioburden and particles, which would clog final filters prematurely.
Separation Goals
● Prefiltration
Remove colloidal and particulate contaminants to extend the service life of downstream sterilizing filters
● Final filtration
Provide a sterile filtrate meeting the requirements of current regulatory
Application Requirements
● Final sterilizing filters should remove bacteria without altering the effects of drug products. Therefore, these filters should have low adsorption of active pharmaceutical ingredient (API), low extractables, be non-pyrogenic and integrity testable, and be sterile or can be sterilized.
● Prefilters and final filters should have enough flow rates. Final filters in the filling machine must have strong structures to prevent media flexing during pulsed flow filling processing, which will result in particle release, drips or other dispense problems.
Recommendation
| Filtration Step | Recommendation |
| Prefiltration | PP |
| Sterile venting | IPF |
| Final filtration | PES |
