MEMBEKAL, MENGHANTAR, MENGUJI DAN ...hsibu.moh.gov.my/hsb.bm/wp-content/uploads/2015/08/Q023S.pdf2 MEMBEKAL, MENGHANTAR, MENGUJI DAN MENTAULIAH PERALATAN PERUBATAN BAGI SATU (1) UNIT

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MEMBEKAL, MENGHANTAR, MENGUJI DAN MENTAULIAH PERALATAN PERUBATAN BAGI SATU (1) UNIT AUTOCLAVE (STEAM STERILIZER) UNTUK

JABATAN CSSS, HOSPITAL SIBU, SARAWAK BAGI TAHUN 2015

NO. SEBUTHARGA: HS/Q023/2015

NO. DESCRIPTION COMPLIANCE TO REQUIREMENT:

YES / NO

COMMENTS / PROPOSED SPECIFICATION

1. APPLICATION

The steam sterilizer shall be designed for the sterilization of wrapped

materials which includes surgical dressing and medical equipments used by

the hospital.

2. SCOPE OF WORK

The scope to be covered under this specification is as listed here under :-

2.1 Supply, install, test and commissioning of the new Steam Sterilizer

and all necessary equipment and parts for the proper and efficient

functioning of the equipment at the listed hospital.

2.2 To provide user training to the hospital staff concern after T&C.

2.3 Servicing and maintaining of the above supplied equipment for a

period of Two (2) years from the date of handing over to the health

authorities in good operating condition.

2.4 Scope of work shall also include necessary all necessary renovation

works / preparation of site that has been identified for placement of

new steam sterilizer as well to cart away all debris and rubbish from

the site of the sterilizer.

3. TECHNICAL SPECIFICATION

3.1 Chamber

It shall be of the horizontal loading rectangular type with an outer

jacket and chamber size of 8STU baskets (1 STU basket 300mm W x

300mm H x 600mm L ) Or Bigger capacity.

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YES / NO


3.2 Material of Construction

The chamber, jacket and others shall be constructed from a

combination of materials as shown below :-

3.2.1 Material of Chamber : AISI 316L stainless steel or better

3.2.2 The door material shall be made of Stainless steel AISI

316L or better

3.2.3 Guides inside the chamber shall be of stainless steel

3.2.4 All welding and soldering materials used for the guides

in the chamber shall be of stainless steel

3.2.5 All the Steam piping and Tri-clamp connection / joints

shall be made of stainless steel AISI 316L or better

3.2.6 All frame and panel shall be made of stainless steel of at

least AISI 304

3.3 Construction

3.3.1 The chamber design of the sterilizer shall comply to the

requirements of the Department of Occupational Safety

and Health, Factories and Machinery Act 1967.

3.3.2 The construction and the operation / functionality of the

sterilizer shall be in accordance with acceptable

international standards (The recognition letter / mark

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YES / NO


should be indicated in the offer).

3.4 Door

3.4.1 The sterilizer shall be of pass-through double door type.

3.4.2 It shall be fully automatic and of vertical sliding type.

3.4.3 Door locking and unlocking shall be automatic with

manual override.

3.4.4 Door opening mechanism shall be prevented from

opening until pressure in the chamber is reduced to

atmospheric pressure with the temperature in the

chamber of less than 80 °C.

3.4.5 The door control mechanism shall incorporate a safety

device which will prevent the entry of steam until the

door is fully closed and secured.

3.4.6 The door seal material shall be made from silicon rubber.

3.4.7 A mechanical safety system shall be incorporated to the

door which shall stop the closure of the door if an object

is found in its’ path thus protecting the operator and

loading equipment.

3.5 Monitor Display Control

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YES / NO


3.5.1 Full Colour Touch screen display indicating the real time

cycle phases and parameters.

3.5.2 The control of all stages of the sterilizing cycle shall be

fitted for test purpose or for emergency use by an

authorized person.

3.5.3 The display shall indicate the following components:

3.5.3.1 Graph

3.5.3.2 Pressure

3.5.3.3 Temperature

3.5.3.4 Running Time

3.5.3.5 Remaining Time

3.6 Automatic Process Control

The following sequences of stages shall be provided under automatic

control without manual interference once each operation has

commenced. The stage reached during the operation shall be

comprised of the following :-

3.6.1 Stage 1 : Air Removal / Conditioning

Air is evacuated by vacuum with minimum of at least 4

pulsing phase.

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YES / NO


3.6.2 Stage 2 : Sterilization

Steam shall be admitted into chamber to provide

sterilizing conditions within the chamber load. The

temperature is sensed and maintained in accordance to

the load programme.

Temperature setting:

134oC – 3.5 minutes minimum sterilizing time

(Programmable)

121oC - 15 minutes minimum sterilizing time

(Programmable)

3.6.3 Stage 3 : Drying (Programmable)

Steam shall be removed from the chamber by vacuum

until below atmospheric pressure.

3.6.4 Stage 4 : Air Admission / Vacuum Break

Air shall be admitted into the chamber via bacteria filter

with minimum efficiency of 99.97%.

Total cycle time shall not exceed 50 minutes for 134oC

and 80 minutes for 121oC cycle.

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YES / NO


3.7 Instrumentation

3.7.1 Printed recorder for temperature in relation with time,

cycle number, date and all relevant information.

3.7.2 Mechanical chamber vacuum and pressure gauge.

3.7.3 Mechanical steam (generator) supply pressure gauge.

3.7.4 Mechanical jacket pressure gauge.

3.7.5 Automatic control device for air leak rate test

3.7.6 Cycle indication display.

3.7.7 Door lock indicator.

3.7.8 ‘Not Sterile’ indicator or equivalent in meaning.

3.7.9 Emergency switch button.

3.7.10 Temperature and pressure display

3.7.11 ON/OFF Power supply switch.

3.7.12 Cycle counter

3.7.13 Energy Saving Features preferred

3.7.14 Alarm (visual and audible) – Automatic process check up

& failure correction to be provided with the control

system.

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YES / NO


3.8 Thermal Insulation

The exterior of the sterilizer shall be lagged with thermal insulation

of suitable thickness and material to ensure service temperature of

not more than 55oC (contractor to specify material used).

3.9 Piping and Valves

3.9.1 All steam pipes and valves shall be made from at least

316L stainless steel preferably with hydraulic hygienic

tri-clamp connections for easy maintenance.

3.9.2 The vessel shall be protected by means of pressure relief

valve(s) fitted to the chamber and jacket

3.9.3 Any strainer in the steam, condensate, drain or water

lines shall be located in a readily accessible position.

Strainers in chamber drains shall be properly secured.

3.9.4 The safety valves and discharge pipes shall be of a size

sufficient to prevent an increase in pressure of more

than 10% in the chamber and jacket.

3.9.5 An appropriate steam vent shall be provided to

discharge excess steam outside the sterilizer.

3.10 Loading & Unloading System

The sterilizer shall be provided with the following features:

3.10.1 One unit automatic loading trolley on the loading side of sterilizer

3.10.2 One unit unloading trolley with adjustable height on the unloading

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YES / NO


side of sterilizer

3.10.3 Two (2) units of internal loading cart, sixteen (16) units of STU

baskets (300W x 300H x 600L mm or equivalent) which are stackable when

in use. Baskets shall fit into carriages and sterilizer.

4. AIR COMPRESSOR

4.1 The compressed air requires by the plant for pneumatic controls and

other applications shall be from a compressor system integral with

the plant. All technical specification shall be specified.

4.2 The noise level in the working area shall not exceed 70dBA (The

successful tendered is required to carry out the proper installation to

minimize the noise level of compressor and perform the test after the

installation of the sterilizer is complete).

4.3 Air Admission

Air supplied by the compressor shall be filtered with minimum

efficiency of 99.97%

4.4 The Air Compressor shall comply to the requirements of the

Department of Occupational Safety and Health, Factories and

Machinery Act 1967. A letter of design approval (for the offered

model) from that Department must accompany in the submission of

quotation.

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YES / NO


5. STEAM GENERATOR

5.1

The built-in steam generator shall be mounted under the sterilizer

chamber.

The steam generator chamber and piping shall be made using

stainless steel material with automatic filing & control to ensure

adequate steam capacity to ensure efficiency of the sterilizer at all

times.

A feed water pump driven by a continuous duty motor shall be

incorporated to ensure delivery of adequate water pressure for the

operation of the steam generator.

The Steam Generator shall equipped with minimum & maximum

water level sensor / indicator.

In event that steam generator is not required for use due to

availability of central steam; the successful contractor shall ensure

appropriate connections of all steam pipelines and valves of

sterilizer to the central steam supply.

5.2 The chamber design of the integrated steam generator shall comply

to the requirements of the Department of Occupational Safety and

Health, Factories and Machinery Act 1967. A letter of design

approval (for the offered model) from that Department must

accompany in the submission of quotation.

6. POWER SUPPLY

The contractor shall carry out all necessary electrical works for successful

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YES / NO


installation and operation of the sterilizer including upgrading of existing

electrical power supply if necessary.

7. SAFETY FEATURE

Audible alarm shall be incorporated to indicate the system failure.

8. INSTALLATION AND COMMISSIONING

The contractor shall undertake :

8.1 All minor works on the building for the installation of the equipment

including drainage system.

8.2 To carry out all necessary civil, mechanical and electrical works for

successful installation and operation of the sterilizer (including

upgrading of existing electrical power supply if necessary as well as

all utilities i.e. supply, fix and connect all piping, wiring and plumbing

works etc. necessary for the proper operation of the sterilizer).

8.3 On completion of installation, the contractor shall arrange with the

relevant authority i.e. Department of Occupational Safety and Health

for testing, inspections and issuing of certificates of fitness without

delay.

A letter of design approval (for the offered model) from Department

of Occupational Safety and Health must accompany in the submission

of quotation.

8.4 The contractor shall be responsible to make good all damages done

to the buildings due to transportation, installation and

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YES / NO


commissioning of the unit

8.5 The contractor shall provide the test checklists / instruments /

equipments to perform the tests on sites, which are required before

the installation can be accepted for use in accordance with the

contract, to the satisfaction of Contract Supervising Officer, or

someone appointed by him to act on his behalf in this matter.

8.6 Notice shall be given to the relevant parties seven (7) days in

advance with the proposed commissioning checklist to be approved.

Commissioning shall be carried out in special process in which work

is completed on site in the following order by the contractor :-

8.6.1 Demonstrate the installation of the sterilizer and

connection / termination of engineering facilities in

accordance with good engineering practice (steam,

electrical and water).

8.6.2 Demonstrate the general engineering performance of the

sterilizer.

8.6.3 Test the mechanical and electrical function of the

sterilizer, including safety device.

8.6.4 Test the specific sterilizing performance (validation) for

the class of sterilizer.

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YES / NO


Biological Indicator / steam indicator

Leak Test

Bowie Dick

Full load/wet load of various items – rubber and fabric

cycle (at least 10 cycles). All accessories used during the

testing and commissioning shall be borne by contractor.

9. TRAINING

Upon completion of installation and testing, the successful contractor shall

provide a comprehensive technical training programme for a minimum of 5

personnels (operation, maintenance and trouble-shooting) to the authorized

personnel and operators. The duration of training shall not be less than

three (3) working days. All expenses shall be borne by the contractor.

10. SERVICING AND MAINTENANCE

10.1 The contractor shall be responsible for the servicing and

maintenance for the period of 24 months after the handing over date.

10.2 A minimum of six (6) times services and maintenance work shall be

carried out by the contractor during the warranty period.

10.3 The successful tendered shall submit two (2) sets of operations and

maintenance manuals including Planned Preventive Maintenance

Schedule, circuit diagram, simple instruction on how to operate the

sterilizer, record drawing showing pipe work and spare parts list of

all major functioning components of equipment.

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YES / NO


10.4 The maintenance during the warranty period shall be

comprehensive including the gaskets and filters replacement. All

consumables items during servicing shall be borne by the supplier.

11. STANDARD

11.1 The construction and the operation / functionality of the sterilizer

shall be in accordance with acceptable international standard. (The

recognition letter / mark shall be indicated in the offer).

11.2 The sterilizer must comply to:

CE mark

EN 285 Large Steam Sterilizers.

Medical Device Directive (MDD) 93/42/EEC

Pressure Equipment Directive (PED) 97/23/EC

ISO 9001:2008 Quality Management Systems

ISO 13485:2003 Certification

12. WARRANTY

Minimum warranty period of 24 months after testing & commissioning.

13. STANDARD COMPONENT SET

13.1 The sterilizer should be provided with the following accessories:-

Automatic Loading Trolley 1 unit

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YES / NO


Unloading Trolley (adjustable height)

Loading Cart

1 unit

2 units

STU Basket 16 nos

Elbow length heat resistant glove 2 pairs

Thermal Printer Paper Roller (100 rolls/ box) 1 box

Bowie Dick Test Pack (20 test pack per box)

Steam indicator (250pcs/box)

12 boxes

5 boxes

14. SITE RENOVATION AND OTHER WORKS

14.1 The contractor shall carry out the relevant renovation works on the

building for the installation of the equipment including drainage and

electrical system.

15. OTHER REQUIREMENTS

15.1 Tenderer shall submit supporting documents as described below

during tender submissions:

15.1.1 The technical catalogue of the product and all related

technical information of the model offered.

15.1.2

15.1.3

All other necessary documentation to support the

technical presentation of the product.

If available, the contractor shall attach a copy of MITI

Certificate or MITI Return Approval letter for the model

offered.

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YES / NO


15.1.4

The contractor shall attend the site visit on the date

stated by the hospital for further clarification of the work

scope, specification and work site / area of the Central

Sterile Supply Department.

16 Warranty

Two Year against Manufacturing Defect from Date Commissioning.

Parts availability for at 10 years from date of testing and commissioning.

Breakdown respond time should be within 48 hours within warranty period

Vendor to specified the warranty period for the parts and accessories

17 Service

Free Preventive Maintenance Service 1 X 6 Monthly During Warranty Period.

Supplies have to provide at least two (2) copies of the Operation Manuals in

both soft and hard copy during testing and commissioning.

Supplies has to provide at least two (2) copies of Instructions for use

Manuals with trouble Shoot Guide, Article Numbers Catalogue and ordering

Information.

18 Training

On Site Training By Application Specialist And Factory Trained Personnel On

Operation Clinical Applications Running Self-Test And Basic Trouble

Shooting

** SUPPLIER MUST HAVE AND IS REQUIRED TO ATTACH MEDICAL DEVICES ACT LICENSE.

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Documents

MEMBEKAL, MENGHANTAR, MENGUJI DAN ...hsibu.moh.gov.my/hsb.bm/wp-content/uploads/2015/08/Q023S.pdf2 MEMBEKAL, MENGHANTAR, MENGUJI DAN MENTAULIAH PERALATAN PERUBATAN BAGI SATU (1) UNIT