Medical equipment clean shop design solution
Author: Shenzhen ZhongJian South Environment CO., LTDissuing time:2017-02-21 14:38:23Pageviews:2754【smallinBig】
First, the medical device purification engineering design reference:
1, the international standard \"ISO / DIS 14644\"
2, clean room plant design specifications \"GB50073-2001\"
3, medical equipment packa...
I, Medical device purification engineering design reference:
1, the international standard "ISO / DIS 14644"
2, clean room plant design specifications "GB50073-2001"
3, medical equipment packaging workshop clean room plant specifications "GMP-97"
4, pharmaceutical production quality management practices "GMP-98"
5, clean room construction and difficult to close the specification "JGJ 71-90"
6, ventilation and air conditioning construction and acceptance of norms "GB 50243-2002"
7, the US federal standard "FS209E-92"
According to the relevant specification requirements, the sterile medical equipment production workshop, drug production workshop, medical biology laboratory, operating room and so require the construction of clean rooms in line with relevant standards. In the clean room construction or alteration, can not rely on the final completion and acceptance to ensure the quality of clean room, must be from the design and equipment selection stage on the strict checks in the whole process of construction of the main key points of strict inspection, supervision, The actual use of regular monitoring in order to ensure that the clean room to meet the design requirements and use requirements.
Sterile medical equipment is any marked "sterile" medical device, the production of clean room is to ensure the quality of sterile medical equipment, the basic conditions to control the production of sterile medical equipment environment and regulate its production, to prevent the environment on sterile medical equipment Pollution, clean room must meet the requirements of the provisions of the environmental parameters to build and monitor regularly.
II, Medical equipment purification project construction need to consider from the following questions:
1, medical equipment packaging workshop clean room engineering required purification materials;
medical equipment factory clean room and medical equipment packaging
workshop clean room project design, installation, commissioning,
maintenance and other integrated services;
3, medical equipment packaging workshop clean room engineering air conditioning purification part;
(1) temperature and relative humidity
medical devices in the absence of special provisions, usually require
the temperature in the regulatory standards Standard and Testing 18 ~ 28
C, humidity 45% to 65%, enterprises generally can be controlled within
the requirements. Such as dynamic monitoring found in the requirements, may be indoor production of large equipment.
(2) air volume, the number of ventilation, static pressure difference
the case of the clean room volume, the number of ventilation is
determined by the amount of air supply in the room, and the static
pressure difference depends on the difference between the air volume and
the air volume and the exhaust air volume. The total air volume, the fresh air volume, the total exhaust air
volume and the external pressure difference can be realized by adjusting
the fan speed or the total valve opening degree. The air volume and
pressure of each room can be realized by adjusting the opening degree of
the branch pipe.
actual detection process found that in the regulation of the control by
the air valve on the number of ventilation times a clean room for the
amount of air conditioning, often the same clean area of the rest of
the clean room air volume changes, that is upset the whole clean The air volume distribution, so that the problem becomes more complex. Also often encountered the number of qualified ventilation and poor pressure, this situation is more common in the two. The main reason is that the airtight structure of the guard is poor and the air outlet grid is not easy to adjust.
the dynamic monitoring of the clean room, the flow of personnel, the
shortage of fresh air and the opening of the door are the main reasons
for the change of the pressure difference between the clean rooms. If
the static pressure difference between the clean room and the atmosphere
is different, the dynamic pressure Under the detection is likely due to the flow of people, the new air
volume is not enough to make the pressure difference can not meet the
(3) suspended particles, planktonic bacteria, sediment bacteria
the test conditions can not meet the specified environmental parameters
(temperature and humidity, wind speed, the number of ventilation,
static pressure difference within the specified range) requirements, the
key project suspended particles, plankton or settling bacteria test
results should be considered invalid. Due
to temperature, relative humidity, wind speed, the number of
ventilation, static pressure difference together constitute the clean
room of the micro-climate, clean room maintenance is normal or not
important indications, key processes can be key projects to test the key
process full performance test The Only
in this way can we fully and systematically monitor the production of
clean room, in order to ensure cleanliness of the clean room performance
data, the accuracy of the test department in the key project suspended
particles, microbiological testing should also be carried out at the
same time the temperature, relative humidity, , Static pressure and other prerequisite test.
clean room and sterile medical equipment clean room design in the
temperature, relative humidity, wind speed, the number of ventilation,
static pressure difference on the project testing standards are in
accordance with the "clean plant design specifications" to implement,
pharmaceutical clean room design The problem is also of reference value for sterile medical equipment cleanrooms.
room summer room temperature than the design range of the reasons,
mostly due to the beginning of the clean room to determine the air
conditioning air volume that is the number of ventilation only focus on
meet the cleanliness indicators, ignoring the clean room heat balance
in the production of clean room design and operation process, must
clean room air conditioning air parameters in real time to ensure that
the production of clean rooms throughout the season to maintain the
temperature of 18 ~ 28 C. Temperature
and relative humidity mainly affect the product production process and
the propagation conditions of bacteria, but also lead to the production
operator comfort on the impact of product quality.
(5) air volume, the number of ventilation
medical equipment purification project - sterile clean room engineering
design phase of the air volume to determine, first of all to meet the
corresponding cleanliness level of ventilation requirements, but also
through the hot and wet load check to further determine the air volume,
in the This is based on the selection of high efficiency filters. The air flow rate of the filter should be less than or equal to the
rated air flow, and the efficiency of the efficient (sub-efficient,
ultra-efficient) air filter in the same clean area should be close.
usually the amount of air supply to the clean room, should take the
maximum of the following three: to ensure that the air cleanliness level
of air supply; according to the heat and wet load to determine the
amount of air; to the clean room to supply fresh air the amount. And
the amount of fresh air should be the maximum of the following two
items: the amount of fresh air required to compensate for the amount of
indoor air exhaust and keep the indoor positive pressure; to ensure that
the amount of fresh air per person per hour in the clean room is not
less than 40m3. For a particular clean room project, the number of ventilation to be determined according to the actual situation. Especially the lower requirements of clean, and sometimes the number of ventilation depends on the indoor heat. Generally
according to the indoor staff and equipment of the amount of dust (or
staff of the amount of dust multiplied by a factor) to calculate a
number of ventilation, the two can take the big, sometimes for insurance
purposes, you can multiply a use factor , Calculate the number of ventilation.
dust particles suspended particles and micro-organisms mainly affect
the quality of products, resulting in cross-infection, clean room dust,
bacteria from the outdoor air accounted for 80% to 90%, in the remaining
factors that human, envelope structure, etc. People account for 80% to 90%. Visible, in addition to the outdoor air dust, bacteria, the staff is to make clean room dust particles the main reason. Test data shows that the amount of personnel movements, walking the amount of dust are different.
clean room operator action should be gentle, smooth, should try to
avoid unnecessary action, especially fast moving and other lower limb
movements should be avoided, so as to reduce the clean room dust
production. Choose clean clothes due to different materials and styles, dust production is very different. Should
be preferred Siamese, dense nylon thick clean clothes, this clean
clothes than several other clean clothes dust production less. Clean
room design using epoxy self-leveling painted surface, metal color
steel wall than the use of several other building materials produced
less dust. Therefore, from the personnel control, plant design two aspects, can reduce the number of dust particles in the clean room.
in addition to the control of pollution sources, to reduce the amount
of pollution to prevent particulate pollution clean room, air
purification methods such as the control of indoor pressure, can
effectively prevent outdoor pollution intrusion chamber or prevent
indoor pollution escape outdoors. And with a reasonable air flow organization to effectively eliminate indoor pollution. These routes are related to the amount of air flow (wind speed) or the number of ventilation in the purification system. The clean room is a complex for the number of ventilation, static pressure, temperature, humidity, illumination and so on.
6, clean room design, construction and monitoring, management is equally important. Sterile
medical equipment clean room construction from the beginning of the
design, clean room monitoring and related to their own management
procedures, personnel training operations. Clean
room should be carried out before the operation of the comprehensive
performance verification, throughout the pre-construction design,
project preparation, construction cycle monitoring, after the completion
of static monitoring, the actual production process of dynamic
monitoring. Enterprises should develop a scientific and effective clean room
management system and procedures, management problems and timely
analysis and analysis.
for Design of Clean Industrial Factory of Pharmaceutical Industry"
(GB50457-2008) was promulgated in November 2008 and implemented as of
June 1, 2009, which is another part of "Code for Design of Clean
Factory" (GB 50073-2001) National standards, will provide a guide for the design of pharmaceutical clean plant. With the introduction of operational standards, the monitoring of the
clean room will be an important guarantee for a clean production
The rapid development of sterile medical equipment production clean room plays an important role in improving product quality. Product
quality is not the final detection but by strict process control
production, environmental control is the key to the production process
control, clean room monitoring work to do a good job of product quality
is very important. At
present, the medical device manufacturing enterprises to carry out
clean room monitoring is not universal, the lack of understanding of the
importance of their business. How
to correctly understand and implement the existing standards, how to
clean the plant for a more scientific and reasonable evaluation, how to
clean the operation and maintenance of the plant reasonable test
indicators are enterprises and engaged in monitoring and supervision of
the common concern.
III, Medical equipment clean room construction Note:
(1) site requirements
1, site selection should be considered: the location of the
surrounding natural environment and good health conditions, at least no
air or water pollution sources, but also away from the traffic arteries,
freight yard and so on.
2, the plant's environmental requirements: the plant's ground, the road should be flat can not afford dust. It is advisable to reduce the terrestrial area or control the dust by greening. Garbage, idle items, etc. should not be open storage, etc., in short,
the factory environment should not be sterile medical equipment
3, the overall layout of the plant to be reasonable: not on the
production of sterile medical equipment, especially the clean area has a
(2) clean room (area) layout requirements
level of cleanliness is set according to the sterile medical device
appliance production environment cleanliness level setting guide in
Appendix B of the Sterile Medical Apparatus Production Management Code. Clean room (area) design should pay attention to the following aspects:
1, according to the production process layout. The process as short as possible, to reduce cross-flow, flow, logistics to a reasonable. Must
be equipped with personnel clean room (deposit room, bathroom, clean
clothes service room and buffer room), material purification room (off
outsourcing room, buffer room and double transfer window), in addition
to the requirements of the product with the outdoor, Equipped with sanitary ware room, laundry room, temporary room,
station equipment, cleaning rooms, etc., each room independent of each
other, clean workshop area should ensure that the basic requirements,
with the scale of production to adapt.
2, according to the level of air cleanliness, can be written in
accordance with the flow direction, from low to high; workshop is from
the inside out, from high to low.
3, the same clean room (area) or adjacent clean room (area) does not produce cross-contamination
1) the production process and raw materials will not have a mutual impact on product quality;
2) different levels of clean room (area) between the air chamber or
anti-pollution measures, the material transmission through the double
air purification should be consistent with GB 50457-2008
"pharmaceutical industry clean plant design specifications" Chapter IX
requirements. The amount of fresh air in the clean room should be taken as follows:
1) the amount of fresh air required to compensate for indoor air volume and to maintain positive pressure in the room;
2) no room fresh air should be less than 40m ³ / h.
5, clean room per capita area should be no less than 4 ┫ (in addition
to corridors, equipment and other items), to ensure a safe operation
such as in vitro diagnostic reagents should be consistent with "in
vitro diagnostic reagents production implementation details (Trial)"
requirements. The treatment of negative, positive sera, plasmids or blood products
should be carried out in at least 10,000 levels of environment, with
respect to adjacent areas or maintaining relative negative pressure, and
meet the protection requirements.
7, should indicate the return air, air and water pipeline direction.