Sterile product Technology Advanced Floor and change room facilities.

1. Advanced Sterile
Product
Manufacturing
Technology
ROSHAN H. KHETADE
SKBCOP Kamptee

2. Contents-
 Wall and Floor Treatment
 Change room

3. Wall and floor treatment
 Wall and floor surfaces should be hard, smooth, impervious, non
shedding, non-flaking, non-cracking.
 All corners covered, and with unbroken surfaces.
 A thin layer of 2mm epoxy coating give the desired finish, avoid
cracking and peeling.

4. • Walls must be made up of non -inflammable or
fire resistant material.
e.g.. Stainless steel, Glass, Enamelled steel etc.
• For reduction of fungal growth, 1% of 8-
hyroxyquinolone, pentachlorophenol etc. may add
to the paint.

5. • Internal fittings such as a cupboard, drawers, shelves, and
equipment must be kept to a minimum.
• Floor must be smooth, easy to clean, disinfectant and be
constructed to minimum microbial and particulate
contamination.
• Flexing and non- flexing type of material are used for
construction of floor.

6. • Flexing floor – Materials are made up of synthetic
elastomers of which most commonly used are
polyvinylchloride (PVC). PVC floor is easily
repaired, cleaned, relatively cheap and simple.
• Non – flexing floor – Are made up of hard
inorganic filler substances in a matrix material.
When a concrete is used it must be adequately
sealed with a material resistant to chemicals,
solvents and cleaning fluids.

7. Change Room
• Personnel access to all controlled areas should be
through change rooms. Change rooms concepts and
layouts vary from single closet size room to expensive
multi-room complexes.
• Entrance to a change area is normally through
vestibules whose doors are electrically interlocked so
that both cannot be opened simultaneously, thus
maintaining the necessary air pressure differential to
prevent the entry of airborne contamination.

8. • Upon entry into the change room wash skins are provided for
scrubbing hand forearms.
• Further control may be achieved by using filtered and heated
compressed air for drying to reduce further particular
potential.
• After hands are dry, garments are taken from dispensers and
donned while moving across a dressing bench.

9. • As a final growing step, aseptic gloves are put on
and sanitized. Exit from the change room to the
controlled are is, like entrance, through an
interlocked vestibule.