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Find below details of sterilization Indicators required by a company in Hong Kong . Detailed terms and procedure are available at http://www.nkinfobase.com/sendoffertobuyer.html Contact us
Production specifications:
A) Specification
Item 1 - Supply of Bowie & Dick Test Pack, Single Use
The degree of importance of the clause is denoted by:
Mandatory = M
Desirable = D
Tenderers must indicate below, point by point whether their offered item complies fully with the tender specifications. Details must be given should the offered product differ from the specifications.
The Bowie & Dick Test Pack offered shall incorporate the following components, requirements and features. M/D Yes No (Provide details) (Please tick as appropriate)
1. The Bowie & Dick test pack shall be a steam sterilization indicator conforming
to BS EN 867:2001, Part 4: Specification for indicators as an alternative to the
Bowie & Dick test for detection of steam penetration or equivalent standards.
M
2. The pack shall be single/multiple (correspond to clause 4.1.1) use, disposable,
ready to use with no set up time. The pack shall be able to place either way up
in the sterilizer or otherwise indicated. M
3. The pack shall be able to encapsulate air and other non-condensable gases and
has the diagnostic capability to test for successful air removal from high
vacuum porous load sterilizer.
M
4. The test pack shall consist of 2 components
4.1 Standardized Test Load
4.1.1. The test load shall be a pre-assembled pack presented with the
indicator system already incorporated and intended for single
use or intended for multiple use with a new indicator system
to be inserted prior to each test. M
4.1.2. The test load shall contain a process indicator on the outer
wrap to provide immediate identification of the processing.M
4.1.3. The outer wrap of the test load shall be marked with:
4.1.3.1. Sterilization temperature(s) suitable for use
4.1.3.2. Manufacturers name
4.1.3.3. Batch number
4.1.3.4. Date of Manufacturing (D)
4.1.3.5. Date of ExpiryM
4.2. Chemical Indicator System
4.2.1 The manufacturer shall provide documentary evidence that the
indicator does not release any substance known to be toxic in
sufficient quantities to cause either a health hazard or a hazard
to the intended properties of the product being sterilized,
before, during or after the sterilization process for which it is
designated. M
4.2.2 There shall be no transfer of ink from indicator system. M
4.2.3 The indicator reagent shall be evenly distributed to cover not
less than 30% of the horizontal surface area of the substrate. M
4.2.4 The pattern of indicator reagent distribution before and after
use shall permit clear interpretation of result. M
4.2.5 The indicator system shall show no discernible colour change
after exposure to dry heat at 140 ± 2°C for not less than 30
min. M
4.2.6 The indicator when tested shall show a uniform colour change
after exposure to dry saturated steam at 134°C for 3.5 min., or
at 121°C for 15 min. or at any other time/temperature
combination and the temperature tolerance shall be +1.5 - 0°C
and the time tolerance shall be ± 5 s.M
4.2.7 The endpoint condition of an indicator that has been exposed to
a sterilization process shall not change to an extent that could
lead to an interpretation other than that apparent on removal
from the sterilizer when stored as specified by the manufacturer
for not less than 1 year.M
4.2.8 The indicator shall be marked with the following headings:
4.2.8.1 Date
4.2.8.2 Department
4.2.8.3 Site
4.2.8.4 Machine No.
4.2.8.5 Cycle No.
4.2.8.6 Operator
4.2.8.7 Supervisor
4.2.8.8 Result D
4.2.9 Adjacent to each heading there shall be a clear space not less
than 5 x 20 mm for user to enter the required information at
the time of use.D
5 The manufacturer shall supply information including sufficient instructions
on the use of the indicator to enable correct interpretation of the test results.
M
6 The shelf life of the pack shall not be less than 18 months upon receipt of
goods by the Authority or its representatives
M
7 Manufacturer shall provide evidence of conformity with the BS EN
867:2001, Part 4: Specification for indicators as an alternative to the Bowie
& Dick test for detection of steam penetration standard, or equivalent
standards which shall consist of declaration by the manufacturer and by
independent certification bodies
M
8. Tender sample of 40 nos. shall be submitted with the tender for evaluation. M
Item 2 - Specification
Supply of Rapid Readout Biological Indicator, for 134șC Gravity Steam Sterilization
The degree of importance of the clause is denoted by:
Mandatory = M
Desirable = D
Tenderers must indicate below, point
by point whether their offered item
complies fully with the tender
specifications. Details must be given
should the offered product differ
from the specifications.
The Rapid Readout Biological Indicator is designed for the rapid, reliable
monitoring of steam sterilization processes when used in conjunction with an
Auto-reader
M/D Yes No (Provide details)
(Please tick as appropriate)
1. The biological Indicator shall have a dry spore strip of Bacillus
Stearothermophilus strains ATCC 7953, ATCC 12980, CIP 5281 or NCTC
10003; or other strains or organisms of demonstrated equivalent performance.
M
2. The growth medium shall be contained in a crushable sealed glass ampule. This
medium shall be modified tryptic soy broth with dual indicator system.
M
3. The rapid readout biological indicator shall be designed for the rapid , reliable
monitoring of 1340C gravity cycles.
M
4. One indicator is a non-fluorescent substrate, 4-methylumbelliferyl-alpha-Dglucoside,
and the other is a PH-sensitive indicator dye, bromocresol purple.
M
5. There shall have Macroporous material to concentrate the fluorescence at the
bottom of the vial.
M
6. There shall have a flexible polypropylene vial to hold both the dry spore strip
and the ampule of media.
M
7. There shall have a colored cap with one-way passage for sterilant penetration.
M
8. The air passage shall be covered with a hydrophobic filter as a steam sterilantpermeable
bacterial barrier.
M
9. There shall be a process/chemical indicator on the label of the biological
indicator, which shall change colour when exposed to steam sterilization process.
M
10. Population of Organism shall not less than 1.0 x 105 , Typical Value 1.0 x 106 .
M
11. After sterilization, the vial shall be 'crushed' without spilling to join the growth
media with the processed spore strip and incubated in an incubator with a
reading system.
M
12. A fluorescent reading of the vial with a designed fluorescent reader shall give a
definite 'positive' / 'negative' result. Rectification proof or calibration proof of the
fluorescent reader must be provided to assure the absolute reliability or relative
percentage reliability of the result.
M
13. The final negative processed indicator reading for a fluorescence change shall
not be longer than 3 hours.
M
14. The following information/insert shall appear/available on both the multi-unit
biological indicator packages and the cartons:
14.1 The name and strain of biological indicator organism(s)
14.2 The modes of sterilization to be monitored
14.3 The lot number
14.4 The viable spore population
14.5 The resistance performance characteristics (D-values, survival/kill times)
14.6 Direction for use
14.7 The expiry date
14.8 The recommended storage conditions
14.9 The culture media and condition of use (i.e. temperature and time of
incubation.
14.10 Instruction for disposal
14.11 Name and address of manufacturer and/or distributorM
15. The shelf life of the indicator shall not be less than 18 months upon receipt of
goods by the Authority or its representatives .M
16. Tender sample of 150 nos. together with the loan of appropriate incubators (if
required) shall be submitted with the tender for evaluation and upon
confirmation of tender award to users/ hospitals, free of charge. Otherwise, the
offer will not be considered.M
Item 3 - Specification
Supply of Rapid Readout Biological Indicator, for 134șC Vacuum Assisted Steam Sterilization
The degree of importance of the clause is denoted by:
Mandatory = M
Desirable = D
Tenderers must indicate below,
point by point whether their
offered item complies fully with
the tender specifications. Details
must be given should the offered
product differ from the
specifications.
The Rapid Readout Biological Indicator is designed for the rapid, reliable
monitoring of steam sterilization processes when used in conjunction with an
Auto-reader
M/D Yes No (Provide
details)
(Please tick as appropriate)
1. The biological Indicator shall have a dry spore strip of Bacillus
Stearothermophilus strains ATCC 7953, ATCC 12980, CIP 5281 or NCTC
10003; or other strains or organisms of demonstrated equivalent performance.
M
2. The growth medium shall be contained in a crushable sealed glass ampule. This
medium shall be modified tryptic soy broth with dual indicator system.
M
3. The rapid readout biological indicator shall be designed for the rapid , reliable
monitoring of 1340C vaccum assisted cycles.
M
4. One indicator is a non-fluorescent substrate, 4-methylumbelliferyl-alpha-Dglucoside,
and the other is a PH-sensitive indicator dye, bromocresol purple.
M
5. There shall have Macroporous material to concentrate the fluorescence at the
bottom of the vial.
M
6. There shall have a flexible polypropylene vial to hold both the dry spore strip and
the ampule of media.
M
7. There shall have a colored cap with one-way passage for sterilant penetration.
M
8. The air passage shall be covered with a hydrophobic filter as a steam sterilantpermeable
bacterial barrier.
M
9. There shall be a process/chemical indicator on the label of the biological
indicator, which shall change colour when exposed to steam sterilization process.
M
10. Population of Organism shall not less than 1.0 x 105 , Typical Value 1.0 x 106 .
M
11. After sterilization, the vial shall be 'crushed' without spilling to join the growth
media with the processed spore strip and incubated in an incubator with a reading
system.
M
12. A fluorescent reading of the vial with a designed fluorescent reader shall give a
definite 'positive' / 'negative' result. Rectification proof or calibration proof of the
fluorescent reader must be provided to assure the absolute reliability or relative
percentage reliability of the result.
M
13. The final negative processed indicator reading for a fluorescence change shall not
be longer than 3 hours.
M
Item 3 - Specification
Supply of Rapid Readout Biological Indicator, for 134șC Vacuum Assisted Steam Sterilization
The degree of importance of the clause is denoted by:
Mandatory = M
Desirable = D
Tenderers must indicate below,
point by point whether their
offered item complies fully with the
tender specifications. Details must
be given should the offered product
differ from the specifications.
The Rapid Readout Biological Indicator is designed for the rapid, reliable
monitoring of steam sterilization processes when used in conjunction with an
Auto-reader
M/D Yes No (Provide
details)
(Please tick as appropriate)
14. The following information/insert shall appear/available on both the multi-unit
biological indicator packages and the cartons:
14.1 The name and strain of biological indicator organism(s)
14.2 The modes of sterilization to be monitored
14.3 The lot number
14.4 The viable spore population
14.5 The resistance performance characteristics (D-values, survival/kill times)
14.6 Direction for use
14.7 The expiry date
14.8 The recommended storage conditions
14.9 The culture media and condition of use (i.e. temperature and time of
incubation.
14.10 Instruction for disposal
14.11 Name and address of manufacturer and/or distributor M
15. The shelf life of the indicator shall not be less than 18 months upon receipt of
goods by the Authority or its representatives .
M
16. Tender sample of 150 nos. together with the loan of appropriate incubators (if
required) shall be submitted with the tender for evaluation and upon
confirmation of tender award to the users/hospitals free of charge. Otherwise,
the offer will not be considered.
M
Item 4 - Specification
Supply of Rapid Readout Biological Indicator, for 121șC Vacuum Assisted Steam Sterilization
The degree of importance of the clause is denoted by:
Mandatory = M
Desirable = D
Tenderers must indicate below,
point by point whether their
offered item complies fully with the
tender specifications. Details must
be given should the offered product
differ from the specifications.
The Rapid Readout Biological Indicator is designed for the rapid, reliable
monitoring of steam sterilization processes when used in conjunction with an
Auto-reader
M/D Yes No (Provide
details)
(Please tick as appropriate)
1. The biological Indicator shall have a dry spore strip of Bacillus
Stearothermophilus strains ATCC 7953, ATCC 12980, CIP 5281 or NCTC
10003; or other strains or organisms of demonstrated equivalent performance.
M
2. The growth medium shall be contained in a crushable sealed glass ampule. This
medium shall be modified tryptic soy broth with dual indicator system.
M
3. The rapid readout biological indicator shall be designed for the rapid , reliable
monitoring of both 1210C vaccum assisted cycles.
M
4. One indicator is a non-fluorescent substrate, 4-methylumbelliferyl-alpha-Dglucoside,
and the other is a PH-sensitive indicator dye, bromocresol purple.
M
5. There shall have Macroporous material to concentrate the fluorescence at the
bottom of the vial.
M
6. There shall have a flexible polypropylene vial to hold both the dry spore strip and
the ampule of media.
M
7. There shall have a colored cap with one-way passage for sterilant penetration.
M
8. The air passage shall be covered with a hydrophobic filter as a steam sterilantpermeable
bacterial barrier.
M
9. There shall be a process/chemical indicator on the label of the biological
indicator, which shall change colour when exposed to steam sterilization process.
M
10. Population of Organism shall not less than 1.0 x 105 , Typical Value 1.0 x 106 .
M
11. After sterilization, the vial shall be 'crushed' without spilling to join the growth
media with the processed spore strip and incubated in an incubator with a reading
system.
M
12. A fluorescent reading of the vial with a designed fluorescent reader shall give a
definite 'positive' / 'negative' result. Rectification proof or calibration proof of the
fluorescent reader must be provided to assure the absolute reliability or relative
percentage reliability of the result.
M
13. The final negative processed indicator reading for a fluorescence change shall not
be longer than 3 hours.
M
14. The following information/insert shall appear/available on both the multi-unit
biological indicator packages and the cartons:
14.1 The name and strain of biological indicator organism(s)
14.2 The modes of sterilization to be monitored
14.3 The lot number
14.4 The viable spore population
14.5 The resistance performance characteristics (D-values, survival/kill times)
14.6 Direction for use
14.7 The expiry date
14.8 The recommended storage conditions
14.9 The culture media and condition of use (i.e. temperature and time of
incubation.
14.10 Instruction for disposal
14.11 Name and address of manufacturer and/or distributor
M
15. The shelf life of the indicator shall not be less than 18 months upon receipt of
goods by the Authority or its representatives .
M
16. Tender sample of 150 nos. together with the loan of appropriate incubators (if
required) shall be submitted with the tender for evaluation and upon
confirmation of tender award to users/ hospitals , free of charge. Otherwise, the
offer will not be considered.
M
Item 5 - Specification
Supply of Rapid Readout Biological Indicator, for 121șC Gravity Steam Sterilization
The degree of importance of the clause is denoted by:
Mandatory = M
Desirable = D
Tenderers must indicate below,
point by point whether their
offered item complies fully with
the tender specifications. Details
must be given should the offered
product differ from the
specifications.
The Rapid Readout Biological Indicator is designed for the rapid, reliable
monitoring of steam sterilization processes when used in conjunction with an
Auto-reader
M/D Yes No (Provide
details)
(Please tick as appropriate)
1. The biological Indicator shall have a dry spore strip of Bacillus
Stearothermophilus strains ATCC 7953, ATCC 12980, CIP 5281 or NCTC
10003; or other strains or organisms of demonstrated equivalent performance.
M
2. The growth medium shall be contained in a crushable sealed glass ampule. This
medium shall be modified tryptic soy broth with dual indicator system.
M
3. The rapid readout biological indicator shall be designed for the rapid , reliable
monitoring of 121 0C gravity cycles.
M
4. One indicator is a non-fluorescent substrate, 4-methylumbelliferyl-alpha-Dglucoside,
and the other is a PH-sensitive indicator dye, bromocresol purple.
M
5. There shall have Macroporous material to concentrate the fluorescence at the
bottom of the vial.
M
6. There shall have a flexible polypropylene vial to hold both the dry spore strip and
the ampule of media.
M
7. There shall have a colored cap with one-way passage for sterilant penetration.
M
8. The air passage shall be covered with a hydrophobic filter as a steam sterilantpermeable
bacterial barrier.
M
9. There shall be a process/chemical indicator on the label of the biological
indicator, which shall change colour when exposed to steam sterilization process.
M
10. Population of Organism shall not less than 1.0 x 105 , Typical Value 1.0 x 106 .
M
11. After sterilization, the vial shall be 'crushed' without spilling to join the growth
media with the processed spore strip and incubated in an incubator with a reading
system.
M
12. A fluorescent reading of the vial with a designed fluorescent reader shall give a
definite 'positive' / 'negative' result. Rectification proof or calibration proof of the
fluorescent reader must be provided to assure the absolute reliability or relative
percentage reliability of the result.
M
13. The final negative processed indicator reading for a fluorescence change shall not
be longer than 3 hours.
M
14. The following information/insert shall appear/available on both the multi-unit
biological indicator packages and the cartons:
14.1 The name and strain of biological indicator organism(s)
14.2 The modes of sterilization to be monitored
14.3 The lot number
14.4 The viable spore population
14.5 The resistance performance characteristics (D-values, survival/kill times)
14.6 Direction for use
14.7 The expiry date
14.8 The recommended storage conditions
14.9 The culture media and condition of use (i.e. temperature and time of
incubation.
14.10 Instruction for disposal
14.11 Name and address of manufacturer and/or distributor
M
15. The shelf life of the indicator shall not be less than 18 months upon receipt of
goods by the Authority or its representatives .
M
16. Tender sample of 150 nos. together with the loan of appropriate incubators (if
required) shall be submitted with the tender for evaluation and upon
confirmation of tender award to users/ hospitals, free of charge. Otherwise, the
offer will not be considered.
M
General Specifications Sheet
for
Supply of Sterilization Indicators
Special Notes for Tenderer
Product Offered
Tenderers are requested to submit with tender copies of 2 set (each set in separate file) of the
following for consideration or otherwise offers will not be considered :
1. Certified copy of documentary evidence by an independent laboratory that the product
offered conforms to ISO or equivalent standards applicable to sterilization indicators as
quoted under general specification sheet and individual items.
2. Certified copy of Manufacturer Licence issued by the Government or Health Authority of
the country of origin, if applicable.
3. Certified copy of the authorized certification of compliance to ISO
9001:2000/13485:2003 standards in production and quality assurance system.
4. Quality assurance/control report of the recent lot of the products.
B) Estimated Quantity For Three Years
Item 1: Bowie & Dick Test Pack, Single Use: 81746
Item 2: Rapid Readout Biological Indicator, for 134 șC,
Gravity Steam Sterilization: 13150
Item 3: Rapid Readout BiologicalIndicator, for 134゜C,
Vacuum Assisted Steam Sterilization : 48435
Item 4: Rapid Readout Biological Indicator, for 121゜C,
Vacuum Assisted Steam Sterilization: 6000
Item 5: Rapid Readout Biological Indicator,
for 121゜C, Steam Sterilization: 1500
C) Sample Quantity :
Item 1: 41 nos
Item 2: 151 nos
Item 3: 151 nos
Item 4: 151 nos
Item 5: 151 nos
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