Manufacturing
GOOD
MANUFACTURING PRACTICES FOR THE MEDICAL DEVICE INDUSTRIES
(Dr.
G. L. Jain, Director,
Corporate
Channels India Pvt. Ltd., Udaipur)
|
HEPA EFFICIENCY
EFFECT ON PARTICLE COUNTS
| For 60
airchange / min |
| HEPA Effic. |
99.99 |
99.999 |
99.9999 |
| Escape / Million |
100 |
10 |
1 |
| Escape 180 M |
18000 |
1800 |
180 |
| Add to room/m |
18 |
1.8 |
0.18 |
| Add in 480 min |
8640 |
864 |
86.4 |
| Class : |
|
|
|
| Unloaded room |
1360 |
9136 |
9913 |
|
HEPA
EFFICIENCY EFFECT ON PARTICLE COUNTS
| For 30 airchange
/ min |
| HEPA Effic. |
99.99 |
99.999 |
99.9999 |
| Escape / Million |
100 |
10 |
1 |
| Escape 180 M |
18000 |
1800 |
180 |
| Add to room/m |
36 |
3.6 |
0.36 |
| Add in 480 min |
17280 |
1728 |
173 |
| Class : |
|
|
|
| Unloaded room |
NA |
8272 |
9827 |
|
HEPA EFFICIENCY EFFECT ON PARTICLE COUNTS
| For 60 airchange
/ min |
| HEPA Effic. |
99.97 |
99.997 |
99.9997 |
| Escape / Million |
300 |
30 |
3 |
| Escape 180 M |
54000 |
5400 |
540 |
| Add to room/m |
54 |
5.4 |
0.54 |
| Add in 480 min |
25920 |
2592 |
260 |
| Class : |
|
|
|
| Unloaded room |
NA |
7408 |
9740 |
|
HEPA EFFICIENCY EFFECT ON PARTICLE COUNTS
| For 30 airchange
/ min |
| HEPA Effic. |
99.97 |
99.997 |
99.9997 |
| Escape / Million |
300 |
30 |
3 |
| Escape 180 M |
54000 |
5400 |
540 |
| Add to room/m |
108 |
10.8 |
1.08 |
| Add in 480 min |
51840 |
5184 |
518 |
| Class : |
|
|
|
| Unloaded room |
NA |
4816 |
9482 |
|
BIO-BURDEN
Bacteria
| Part of body |
Bacteria/Sqcm |
| Scalp |
1,500,000 |
| Armpit |
1,000,000 |
| Forehead |
200,000 |
| Back |
50,000 |
| Forearm |
11,000 |
|
BIO-BURDEN
-
Raw Material
-
Packing
Material
- Primary
- Final
|
BUILDING
PLAN
- Location of
factory
- Orientation of
building
- Natural vs.
artificial light
- Air-conditioning
- Light intensity
|
BUILDING
PLAN
- Location of fan
- Clean room
related
- Electricity
points
- False ceiling
- Movement of
man, material and product
|
HUMIDITY
| Temperature (deg. C) |
Air capacity to hold water (g H2O/kg
of air) |
| 5 |
7 |
| 10 |
11.4 |
| 20 |
17 |
| 24 |
22 |
| 30 |
30 |
| 40 |
50 |
|
STERILIZATION
OF MEDICAL
DEVICES
STERILIZATION
The ultimate Destruction of All viable
organisms on or Removal from a product |
STERILIZATION
METHODS
COMMON
- Steam
- Ethylene oxide
- Radiation
- Filtration
|
STERILIZATION
METHODS
LESS USED
- Formaldehyde
- Propylene oxide
- Heat
- Thermo-radiation
|
CONTROLS
- Filtration
- Incoming
inspection of vendor product and supplies
- Written GMP
regulation
- Clothing
- Washing of
hands
- Disinfection’s
liquids
- Fogging
- Mechanical
cleaning procedure
- Rodents and
Insects
|
SOURCES
- Skin surface
bacteria and fungi
- Respiration
contamination
- Hair
- Oil
- Piping,
Reservoir
- Treatment
- Corrosion
- Chemical
- De-mineralize
contamination
- Sewage
|
|
DETECTION
- Fall out plates
- Air sample
- Particle
Counters
- Product
microbial assays
- Observation of
GMP violation
- Safety tours
- Vendor products
incoming inspection
|
|
SOURCES
- Dust particle
generated from soil, cardboard
- Cardboard
fibers
- Skin shedding
- Machinery
- Wood
- Paper
- Plastic
- Oil fumes
|
|
|
|
|
|
