Section 3 equipments

Equipment shall be of appropriate design, construction, size and

suitably located and to facilitate cleaning and maintenance
3.1 design and construction
- Requirements:
the equipment surfaces shall not be reactive, additive or absorptive
so as to alter the drug
shall not adversely effect the product
materials rqd for sp operations (lubricants and coolants) shall not
come in contact w/ in process materials so as to alter the finished
product
equipments - easily and conveniently cleanable
equipment for flammable or chemical subs. must be explosion
proof/fire proof
equipment employed for weighing etc. shall be regularly checked and
calibrated and recorded. Calibration - traceable to a primary std of a
reliable agency
Filters for liquid filtration shall not release fiber or subs into such
products
3.2 installation and location
- E shall be suitably instilled and located to avoid cross contamination
- Equipment shall have sufficient distance w/ each other to avoid
congestion and ensure products are not admixed or confused w/ each
other
- Belts and pulleys shall be equipped with safety guards. Water, steam
and pressure or vacuum lines shall be installed so as to be easily
accessible
- Equipment shall be marked with an identifying number. This will be
used on all batch directions to designate a unit
- All pipes, tanks, jackets for steam or coolant shall be properly
insulated to prevent injury and energy loss.
- Piping to equipment with pressurized steam shall be trapped and
drained.
- Heating, ventilation, air, water, steam, gases and other support
systems must undergo validation.
Maintenance
- Equipment - regular maintenance checks at appropriate intervals to
prevent malfunctions that can alter the product
- Written procedures shall be followed for maintenance of equipment.
The preventive maintenance program shall be structured to assure:
- all equipment requiring preventive maintenance is identified
- the preventive maintenance schedule
- the frequency for preventive maintenance for each equipment
is identified
- the maintenance records are kept

- that a preventive maintenance activity for critical pieces of

equipment exceeds the scheduled time interval for that activity,
quality assurance is advised of the deviation in the maintenance
schedule.
A written record of major equipment maintenance and use shall be
included in logs which also identifies batch processed.
A comprehensive program shall cover equipment calibration