PDD Process Lecture Flashcards
Lyophilization
Refers to a dehydration process for a perishable material
- Injections are unstable
- Extracts the water from drugs and other products = remain stable
Process of Lyophilization
Sublimation
- Freezing the product so that the water in the product becomes ice
- Sublimating the ice directly into water vapor by applying vacuum
Drawing off the water vapor
Freeze-die products and removed from the machine
Lyophilization Advantages
Stored in dry state Dried without elevated temperature Sterile Rapid reconstitution Good for air-sensitive drugs
Lyophilization Disadvantages
Not suitable for volatile
Expensive
Instability
Spray Dry
Solution of a drug is placed into the drying chamber where it passes through an atomizer that creates an aerosol of small droplets
Aerosol come sin contact with a hot sterile gas usually air
Solvent evaporates quickly
Sterilization
Purpose is to destroy or eliminate microorganisms that are present in a preparation
Methods depend on nature of preparation
Steam Sterilization
An autoclave and employs steam under pressure
- Destroy via denaturation and coagulation
121 C for 20 minutes
Not suitable for oil based formulation
Steam Air Mixture
Good for prefilled syringes
Inefficient
Batch process
Dy Heat Sterilization
Ovens are heated either by gas or electricity and are generally thermostatically controlled
160-170 for 2+ hours
Effective for depyrogenation
Sterilized by moist heat
Sterilization by Filtration
Physically removed by absorption on a filter medium or by a sieving mechanism but are not destroyed
Pores are .2 micrometers
Heat sensitive materials nad lyophilized sterile powders
Gas Sterilization
Exposure to ethylene oxide or propylene oxide gas
Kills by interference with the metabolism of bacterial cells (alkylating agent)
Effectiveness depends on humidity, concentration and temp
Employed to sterilize heat sensitive and moisture sensitive material
Gas Sterilization
Hydrogen peroxide (vapor phase hydrogen peroxide VPHP) - Facility sterilization
Sterilization by Ionizing Radiation
Destroy cellular structure DNA
Effective for ointments
Bandages, baby bottle nipples
Change polymer/API characteristics
Manufacture of Parenterals
Special floor plans: Filtered air supply, use of UV light, sterile, access)
HEPA Filter
Filters air
Facility design
Low traffic area Wire shelved Cool A positive airflow Ceiling should be non-porous and non-shedding Eliminate cracks Change disinfectants
Clean Room and IV room Personnel
People: contamination
Restricted access
No talking except via phone or intercom
Sterility Testing
Determine the probable sterility of a specific batch
- Direct introduction to culture medium or filtering test samples
Pyrogen Testing
Cause fever, chills, pain, malaise
Quantitative biological test based on fever response in rabbits
Limulus Amebocyte Lysate Test (LAL Test)
In vitro detection of pyrogen
– Horseshoe craps
Reacts with LPS
Leaker Testing and Sealing Verification
1% methylene blue and applying vacuum (25 in for 25 min)
Ampoules are then washed and checked if there is any blue solution
Clarity and Particulate Analysis
State or quality being clear and transparent to the eye
Physical Complications
Infection Central Catheter Misplacement Hypothermia Neurotoxicity Phlebitis Extravasion Thrombosis Hemolysis Pain Air Embolism Allergic Reactions
Infection
Central IV Lines
Contaminated tuing or catheter
