Manufacturing
GOOD
MANUFACTURING PRACTICES FOR THE MEDICAL DEVICE INDUSTRIES
(Dr.
G. L. Jain, Director,
Corporate
Channels India Pvt. Ltd., Udaipur)
|
Steam
- Oldest
- Most useful and reliable
- Protein coagulation
- Home pressure cooker
- Pure
- Standard steam
- No air
- No contaminants
|
STEAM : Conditions
Steam Temp/pressure : 121 deg C /15 psi
Air removal Temperature
Nil 121
1/2 112
1/3 109
full 100
Time 30 minutes after achieving 121 deg C.
|
steam : Method
Gravity or downward displacement
High vacuum
Air density = 0.12 lb/cuft
Steam = 0.07 lb/cuft
|
ETHYLENE OXIDE
Method
A. 100% gas
- Air removal
- gas admission
- exposure
- final vacuum
- release of vacuum
- aeration
|
ETHYLENE OXIDE
Method
B. Mixtures
- Pressure vessels
- Mc Donald cycle
- High vacuum system
- Air displacement cycle
- No vacuum
|
ETHYLENE OXIDE
- Colorless gas
- Heavier than air
- Flammable and highly explosive (3-80% in air)
- Extremely reactive
- Chemical alkalization
- Hydroxyl
- Sulfhdryl
- Carbonyl
- Phenolic
|
ETHYLENE OXIDE
ADVANTAGES
- Less effect on plastic
- High penetration capability
- Rapid microbial effect
- Low temperature range
- Cost effective
|
Ethylene oxide
DISADVANTAGES
- Determental effect on material
- Toxic bio-product
- Mutagenic
- Carcinogenic
- Many parameters to be controlled
|
GAMMA RADIATION
| Radiation : |
Electro magnetic |
| Wave Length : |
0.01-0.1 Ao |
| Action within DNA : |
Distruption of molecular bond |
| Source : |
Cobalt 60- nickle 60 |
| Energy : |
>0.5 mev < 10mev |
|
GAMMA RADIATION
| 1 g cobalt : |
1000 Curie |
| curie : |
0.015 watts |
| Capacity General : |
15 kW |
| Dose : |
2.5 Mrad |
| Overdose ratio : |
1:1 |
|
GAMMA RADIATION
EFFECT
Free radical · Ionization
Degradation · Excited molecules
|
GAMMA RADIATION
EFFECT
- On plastic molecules
- Impact strength
- Tensile strength
- Elongation
- Elastic modulus
- Electric properties
- Optical properties
|
Sterility testing
- Purpose
- Media
- Sampling
- Method
- Selections
- Procedures
|
|
|
|
|
