Sterile medical equipment clean room part set requirements
Summary:
Dongguan
City, Dongguan City for the mechanical and electrical purification of
sterile medical equipment clean room clean room (district) level of the
principle of setting, and medical equipment plant on the work,
production and plant environmental requirements, the overall layout of
the rationality and clean production area production process and Static pressure and other requirements.
Key words:
Medical equipment clean room clean room clean area environmental
requirements layout production area cleanliness level set principle
Requirements for working environment
If it is possible to adversely affect the quality of the product, the
working environment conditions should be made quantitative or
qualitative provisions
Including from the purchase of raw materials (from the delivery or
transport); to storage, production and processing, monitoring and
measurement, as well as finished product storage, transportation, etc.,
until the product delivered to customers so far.
Develop environmental conditions to control program documentation or
work instructions to monitor and control environmental conditions
If the environmental condition control is a special process, the process should also be confirmed.
Production environment requirements
Site selection should be considered
The surrounding natural environment and health conditions are good, at
least there is no air or water pollution sources, should be away from
the traffic arteries, freight yard and so on.
Plant environmental requirements
Plant ground, the road should not be easy to dust. It is advisable to reduce the terrestrial area or control dust by greening. Garbage, idle items, etc. should not be open storage, etc., in short,
the factory environment should not be sterile medical equipment
production pollution.
The overall layout of the plant is reasonable
Not on the sterile medical equipment production area, especially the
clean area has a negative impact; flow, logistics should be separated.
On the new, expansion of the sterile medical equipment manufacturing
enterprises, the proposed by the pharmaceutical industry clean factory
design qualification of the unit design.
Clean production area
Determine the process of production in the clean room (area)
Analyze, identify and identify processes that are produced in a clean
room (area) and identify them in the relevant technology or process
documentation.
Cleanliness (area) cleanliness level to meet the "set principle" requirements.
"Set the principle" can not cover or not a single purpose of the
product, the environmental cleanliness level to the product similar to
the same use or similar to rely on the principle should be high should
not be low on the low must be verified.
Clean room (area) static pressure requirements
Different levels of clean room (area) between ≥ 5Pa, clean room (area) and outdoor ≥ 10Pa
There should be differential pressure indicating device.
The same clean room (area) between the pressure gradient is
reasonable: the relatively high demand for a higher pressure, if the two
processes may have a certain impact, fear of the higher impact.
Clean room (area) cleanliness level set principle
First, the use of pollution to minimize the production technology to
ensure that medical devices are not contaminated or can effectively
eliminate pollution.
Advocate for technological progress, it is recommended to use advanced production technology.
Advanced production technology, equipment, tooling and facilities.
In the process of product formation to minimize the human factors, the
maximum extent that the product is not exposed to the operating
environment, as far as possible to avoid direct contact with the
product.
Second,
the implantation and intervention into the blood vessels and the need
for a hundred times in the local 100-class clean area for follow-up
processing (such as filling letters, etc.) equipment, not cleaning parts
processing, cleaning, assembly, And its sealing, not less than 10000 level.
Implanted into the blood or the heart of the device, such as: vascular
stent, heart valve, artificial blood vessels, pacing electrodes,
artificial arteriovenous fistula, vascular grafts, in vivo drug release
catheters and ventricular assist devices.
Intervention into the blood of the device, such as: a variety of
intravascular catheter (such as central venous catheter), stent delivery
system.
Third,
implanted into human tissue, with blood, bone or non-natural cavity
directly or indirectly contact the device, (not cleaning) parts
processing, the end of cleaning, assembly, the initial packaging and
sealing, not less than 100000 level.
Devices implanted into human tissue, such as pacemakers, drug delivery
devices, neuromuscular sensors and stimulators, artificial tendons,
breast implants, artificial laryngeal, subperiosteal implants and
ligaments.
Instruments that are in direct contact with blood, such as plasma separators, blood filters, and the like.
And
the blood on a certain point of contact, as a pipeline to the vascular
system input device, which is indirectly through the liquid or blood and
blood contact with the human body, such as: one-time use of infusion,
one-time use of blood transfusion, one-time use of intravenous infusion Needles, extenders, transfer devices and so on.
Mainly in contact with bone equipment, such as: orthopedic nails,
orthopedic panels, artificial joints, bone prostheses, artificial bone,
bone cement and bone equipment.
Fourth, with the body damage the surface and mucosal contact
equipment, (not cleaning) parts of the processing, the end of fine
washing, assembly, the initial packaging and sealing, not less than
300000 level.
Contact with the injured surface (wound or other damage to the body
surface) contact equipment, such as: ulcers, burns, granulation tissue
dressings or treatment equipment, "Band-Aid" and so on.
Contact with the mucous membrane or natural cavity device, such as:
sterile catheter, sterile tracheal intubation, which is characterized by
no puncture or incision into the body of the device.
Fifth, the initial packaging materials production environment requirements
And the use of sterile medical equipment in direct contact with the
surface, do not clean the use of the initial packaging materials, should
follow the same degree of cleanliness of the production environment and
the principle of the original packaging materials to meet the quality
of packaging sterile medical equipment requirements.
Such as intravascular catheters, artificial breasts, catheters and other primary packaging materials. If the initial packaging material is not in direct contact with the
surface of the use of sterile medical equipment, not less than 300000
level.
Such as disposable infusion sets, disposable blood transfusions, disposable syndromes such as sterile syringes.
6, for the requirements or aseptic processing filling, at 10 000 under the local 100 clean area.
Such as vascular support of the pressure grip, Tu drug;
Blood bag production of anticoagulants, maintenance liquid filling;
Liquid products for aseptic preparation and filling;
As well as sterile treatment, transport and packaging of solid products that can not be finalized in their containers.
7, clean work clothes cleaning, drying and wearing clean clothes
service room, special station equipment cleaning and disinfection of the
end of the area of air cleanliness level can be lower than the
production area of a level.
Disinfection of sterile work clothes can be clean in 100000 clean
areas, but after finishing the sterilization, storage should be 10,000
clean room (area).
Clean uniforms cleaning, finishing the minimum level of 300,000 clean areas.