JB/T 20032-2012 English PDF (JBT20032-2012)

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JB/T 20032-2012: Series vacuum freezing dryer for pharmaceutics
JB/T 20032-2012
JB
PHARMACEUTICAL MACHINERY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.30
C 92
Record No.. 36764-2012
Replacing JB 20032-2004
Series vacuum freezing dryer for pharmaceutics
ISSUED ON. MAY 24, 2012
IMPLEMENTED ON. NOVEMBER 1, 2012
Issued by. Ministry of Industry and Information Technology of the
People's Republic of China
Table of Contents 
Foreword ... 6 
1 Scope ... 8 
2 Normative references ... 8 
3 Classification and marks... 9 
4 Requirements ... 9 
5 Test methods ... 12 
6 Inspection rules ... 16 
7 Marks, user instructions, packaging, transport and storage ... 18 
Series vacuum freezing dryer for pharmaceutics
1 Scope
This Standard specifies the classification and marks, requirements, test
methods, inspection rules, marks, user instructions, packaging, transport and
storage of series vacuum freezing dryer for pharmaceutics.
This Standard is applicable to series vacuum freezing dryer for pharmaceutics
(hereinafter referred to as the freezing dryer).
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB 150-1998, Steel pressure vessels
GB 151-1999, Tubular heat exchangers
GB/T 191, Packaging and shipping icon logo
GB 5226.1-2008, Electrical Safety of Machinery - Electrical Equipment of
Machines - Part 1. General Requirements
GB/T 9969, General Principles for Preparation of Instructions for Use of
Industrial Products
GB/T 10111, Generation of random numbers and procedures applied to
sampling inspection for product quality
GB/T 13306, Plates
GB/T 13384, General specifications for packing of mechanical and electrical
product
GB/T 16769, Metal-cutting machine tools - Measurement method of sound
pressure level
YY/T 0216-1995, Editorial nominating method for the model designation of
pharmaceutical machinery
not be less than 5°C.
4.3.9 The drying oven and the steam trap shall be installed with illuminated
mirror with safety voltage.
4.3.10 The automatic tamping operation shall be stable, no crawling
phenomenon is allowed, and the pressing force can be adjusted.
4.3.11 The vacuum control system of the freezing dryer shall be equipped with
a sterile filter and be able to perform integrity testing.
4.3.12 The user operation permission setting of the freezing dryer control
system shall not be less than three levels.
4.3.13 The process parameters of the freezing dryer control system shall be
able to set, control, display and record. The operation state shall be displayed.
4.3.14 The drying oven door of the steam sterilizing freezing dryer shall have
safety interlocking device. When the temperature in the oven is less than 40°C
and the pressure is equal to atmospheric pressure, the oven door can be
opened.
4.3.15 The freezing dryer shall be able to perform cleaning in place of the
inner surface of the drying oven and shelves on each floor.
4.3.16 The freezing dryer shall be able to perform sterilization in place of the
inner surface of the drying oven and shelves on each floor, which is certified as
sterile.
4.3.17 When the freezing dryer is in operation, its noise value shall not exceed
78dB(A) of sound pressure level.
4.3.18 The absolute pressure of the drying oven and steam condenser after
45min vacuuming shall be no more than 2.7Pa.
4.3.19 The vacuum leak rate of the freezing dryer and steam condenser shall
not be greater than 0.025 Pa·m3/s.
4.3.20 The capture capacity of the steam trap is not less than 10 kg/m2 per
24h at an absolute pressure of 2.7Pa.
4.4 Electrical safety performance
4.4.1 The continuity of the protection and connection circuit of the electrical
system shall comply with the provisions of 8.2.3 of GB 5226.1-2008.
4.4.2 The insulation resistance of the electrical system shall comply with the
provisions of 18.3 of GB 5226.1-2008.
the liquid nitrogen freezing dryer. Check whether the control system has the
status of each component, and whether the control data is displayed or
recorded.
5.3.14 Safety interlock test.
a) When the temperature in the drying oven is greater than 40°C, the drying
oven door lock mechanism cannot be opened.
b) When the pressure in the drying oven is greater than atmospheric
pressure, the drying oven door lock mechanism is opened.
5.3.15 In-place cleaning test.
Spray 3% concentration of riboflavin solution on the wall of the drying oven and
the shelf surface. Wait for 30 minutes to start cleaning in place. After the
cleaning, the hand-held violet light with a radiation wavelength of 320 nm to 400
nm and an irradiance of 1000 μm or more and W/cm2 shall be used, and the
dark spot is observed at a distance of 38 cm from the surface to be measured.
Check the dry box wall and shelf surface.
5.3.16 In-place sterilization test.
After cleaning the drying oven, the biological indicator made from the spores of
the thermophilic spores is placed on the shelf in the drying oven. When the cold
spot temperature rises to 121°C and the pressure reaches 0.11MPa, the
biological indicator shall be taken out after 30min of incubation and placed
directly at 56°C~60°C for 24h~48h. After removing, determine the sterilization
effect according to the color reaction. The sterilization shall be qualified after it
is cultured, removed and remains purple. The sterilization shall be unqualified
if it turns yellow.
5.3.17 Noise test.
In the normal operation of the freezing dryer with a sound level meter according
to GB/T 16769 test method to test the noise of the freezing dryer.
5.3.18 Absolute pressure test of freezing dryer.
Dry the drying oven, steam condenser and vacuum pump under dry conditions
of the drying oven and steam condenser. After starting the vacuum pump to
vacuum the drying oven and vapor condenser for 45min, check the vacuum
degree.
5.3.19 Vacuum leakage rate test of freezing dryer.
When the pressure in the drying oven and steam condenser reaches 5Pa, close
the vacuum pump of the isolation valve and keep the pressure for 30min, record
7 Marks, user instructions, packaging, transport and
storage
7.1 Marks
7.1.1 Each freezing dryer shall fix the product label in a conspicuous position.
The size and requirements of the label shall comply with the provisions of GB/T
13306.
7.1.2 The freezing dryer label shall contain the following information.
a) product name and model number;
b) product main parameters;
c) product number and manufacturing date;
d) name of manufacturer, trademark;
e) product standard number.
7.1.3 The packing box storage and transport marks shall meet the
requirements of GB/T 191. Outside the packing box, there shall be the following
information.
a) product name and model number;
b) shipping date;
c) names of sender and receiver;
d) name of the sending and receiving stations;
e) gross weight, overall dimensions;
f) packaging, storage, and transport graphic marks.
7.2 User instructions
The user instructions of the freezing dryer shall meet the requirements of GB/T
9969.
7.3 Packaging
7.3.1 The packaging of the freezing dryer shall meet the requirements of GB/T
13384.