DOC《Clean steam generator纯蒸汽发生器》

Clean steam generator纯蒸汽发生器 Intended use: Designed to generate clean steam for sterilization of pipelines and capacitive equipment as well as to provide the work of sterilizers in pharmaceutical production.

用途:产生清洁蒸汽用于消毒管线和电容设备,同时提供医药生产的消毒工作. Capacity:产能 Feed steam pressure, bar 蒸汽压力 Capacity, kg/h小时/公斤

4 -

6 1000 Equipment:设备 - FW injection pump manufactured by Grundfos, 由Grundfos生产的FW注射泵 - system of measurement and adjustment of the level in columns 测量和调整塔器水平的系统. - industrial steam feed control system 工业蒸汽供给控制系统 - clean steam feed control system 干净蒸汽供给系统. - clean steam flowmetering system 干净蒸汽流量系统 - particulate matters filtering, separation and condensate separation system at the inlet of industrial steam to steam generator 在工业蒸汽进入蒸汽发生器入口的细小物体的过滤器,分离和冷凝分离系统 - valves/control produced by Gemu or Burkert 由Gemu or Burkert生产的阀 steam and condensate components produced by Spirax sarco. 由Spirax sarco生产的蒸汽和冷凝器件. Materials: stainless steel, all feed water and clean steam-contact parts should be manufactured of materials 1.4435/1.4404 (according to USA AISI

316 L or AISI

316 Ti standards), other parts C of material 1.4301 (according to USA AISI

304 standard). 材料: 不锈钢:所有注入的水和清洁蒸汽接触的部件按USA AISI

316 L or AISI

316 Ti标准,其他部件按USA AISI 304标准. Welded joints shall be carried out by means of inert gas welding. All units of the installation should be accessible for inspection and easily dismantled. 用惰性气体焊接. 所有安装的单位可以拆解检验,并容易拆卸. Surfaces: 表面抛光 - polished inside 内部Rа <

0.6 ?m - abraded outside外部 Rа <

0.9 ?m -welded joints of the machine units in working areas shall be polished to the base metal state. Shell metal C polished stainless steel. 设备焊接部件在工作区域应当抛光到基础状态. 外壳抛光不锈钢. Basic control and automation functions:基础控制和自动功能 -- PLC controller and sensor control panel on the basis of Simatic Siemens 用西门子Simatic PLC和传感控制操控台 -- level monitoring of source water in the first distiller column 第一个蒸馏塔水位监视 -- steam pressure and heating control 蒸汽压力和加热控制 -- compressed air pressure control 压缩空气压力控制. -- clean steam pressure control with an output of (4-20) mA for external tabbing 4-20mA输出的干净蒸汽压力控制用于外工作台. -- permanent control of clean steam parameters with the help of clean steam condensate conductivity, with possibility of registration of inlet (FW flow) and outlet (electric conductivity of condensate and clean steam pressure) parameters from (4-20) mA output for external tabbing of digital monitor 在清洁蒸汽冷凝传导的帮助下,(冷凝和清洁蒸汽压力的电传导)出口参数 -- respiratory filter and valves for air bleeding from steam generator 通过蒸汽发生器流过的空气呼吸过滤器和阀门 the printout or digital version of PLC controlling program with comments PLC controlling program with comments can be printout 可以打印PLC控制程序内容 -- the possibility of SCADA Ethernet interface connection to the system SCADA 以太网界面连接系统 Documentation: - pressure vessel certificate translated into Ukrainian or RussianEnglish and executed on form provided in Appendix

3 (Guidelines on Vessels), with drawings, connection diagram and stress analysis of the vessel and its elements (the vessel should be made with compliance to the regulations of State monitoring of work safety) and weld crack detection;

压力容器证书英文版,带图和连接

图表和容器压力分析和原理(所做容器应该和国家安全监察规定相符. - certificate for connecting pipelines;

连接管道证书. - documents on performed inspection and testing while production of the pressure vessel;

压力容器生产时的检查和测试文件 - instruction on equipment assembly and disassembly (installation instruction);

安装说明 - equipment mounting instruction;

设备装配说明. - operating instruction;

操作说明 - equipment cleaning instruction;

清洁说明 - maintenance instruction (Maintenance Schedule, servicing and full repair works);

维修保养说明(维修计划,服务和全部的修理工作. - problem checklist and troubleshooting methods;

故障处理表 - certificates for component parts;

部件的合格证书. - certification for the valve and instruction on the safety valve adjustment with indication of the valve flow coefficient for compressible and non-compressible media as well as installation area;

- specifications for all equipment elements;

- certificates for materials and control valves;

- up-to-date sheets on gauging, validation and calibration of measuring equipment;

- software certificate of conformity;

- documentation in theEnglish Russian or Ukrainian language. Description of produced clean steam: Value name Permissible rates Temperature (123 ( 140)(С Specific conductivity ≤1,1 ?S/cm at 20°С Description Water steam condensate C transparent colourless liquid, odorless and tasteless. Chlorides Not more than 0.00005 % (0,5 ррm). Nitrates Not more than 0.00002 % (0,2 ррm). рН 5.0 C 7.0. Heavy metals Not more than 0.00001 % (0.1 ррm). Oxidants Pale-pink colour should not disappear Bacterial endotoxins Not more than 0.25 МЕ in

1 ml Total organic carbon level (TOC level) Up to

500 ppb Feed water characteristics C the possibility of the steam generator running with the feed water with specific conductivity of up to 4.3 μS/cm C

1 at 20°С. Characteristics of industrial steam at the steam generator inlet C pressure of

4 C

6 bar, Operating costs: Please, provide the spare and wearing parts list as well as the materials subject to planned change during equipment operation, their price, change intervals and manning level necessary for maintenance schedule works performance. The information should be time-ranged: from the day of commissioning until the full repairs term. 消毒柜 Destination: sterilizer for sterilization injectable drugs in glass ampoules with the possibility to control hermetic of ampoules by a crash-test or vacuum test. Productivity: working volume of sterilization chamber should provide simultaneous sterilization of

98 cassettes with ampoules size 300*300*100 mm, with a total cycle time (sterilization + vacuum check + drying) - not more than

3 hours (or smaller size chambers with a longer cycle time) Volume of chamber

1400 -

1500 liters. Volume of casing (jacket)200 -

250 liters. Number of ampoules

10 ml in a single download -

32 000 pcs Number of ampoules

5 ml in a single download C

47 000 pcs. Number of ampoules

2 ml in a single download C

80 000 pcs. Number of ampoules

1 ml in a single download C

80 000 pcs. Working conditions: Working pressure:1 + 2.5 bar. Casing:1 + 5,0 bar. Working temperature from 70°С to 137°С at the maximum allowable pressure of 2.5 bar. According to DSTU ISO 11134:2003 Sterilization of medical products. Requirements for conformity assessment and streaming control. Industrial wet heat sterilization. Sterilization effect F0 must be not less than

15 minutes . Time of sterilization must be not longer than

3 hours (time includes sterilization + checking for leaks + drying ). Options: - sterilization with pure steam;

- sterilization with superheated water;

- sterilization with air-steam mixture;

The supplier must specify the benefits of sterilization type, which he suggested, with the ratio of : price/quality, cost of equipment / operating cost, time of the process, using efficiency of chambers volume compared with other types of sterilization. Provide: horizontal, two-door (passing through) sterilizer type temperature and pressure management and control during the process( in chamber and casing) security control equipment in chamber and casing (jacket) presence of a flexible sensor for monitoring temperature in the product pall filter for air supply into the chamber the possibility of an emergency stop regulation of sterilization is carried out by pressure and temperature with conversion t F0 equipped with doors on sliding bearings possibility to adjust sterilizer height heat-isolating outer casing is made of steel AISI

304 with high-quality isolation cover must be easily removable the ability to install doors for access to the technical area device to measure the amount of air and non-condensed gas in the sterilization cycle for the registration of possible chamber leaks, not identified in the performance of the vacuum test. the required number of temperature sensors Control panel with ?touch-screen? display with the possibility of an ergonomically optimal installation. the possibility of changes in process parameters (temperature, time, pressure, depth of vacuum);

preservation of the various programs in memory registration of process parameters: temperature, time, pressure, storage, program execution memory. thermal printer for printing checks with the program parameters performance. Check shows: the identification number of sterilizer, date and time of sterilization, temperature and pressure changes over time, the process cycle. Ability to print saved processes of previously performed sterilization. the use of vacuum test and the Dick Bove-test programs. manual release of pressure in case of emergency door locking system when the chamber is under pressure and if there is presence of foreign object near the doors. Provide equipment: Vacuum liquid-packed ring pump. Blow-off valve in chamber and jacket. All pipeline connections and isolation valves must be ?Tri-clamp? type. Type of attachment ?Tri-clamp? for sterilization connection to workshop utilities. SIEMENS Software. Trolleys with directing or perforated shelves for transporting, loading, uploading, and sterilization of ampoules in cassettes, in an amount not less than

2 pieces. Shut-off-and-regulating fixtures of average and membranous GEMU type. Material: chromium-nickel steel. All details which connects with product must be made of materials according to standard USA AISI

316 L, the rest of materials according to standard USA AISI 304. Isolation must provide the temperature of external jacket surface not more then 45°С. Seal material PTFE or EPDM Surfaces: - polished inside Rа<

0,8 ?m - field welds of machine units in working areas must be etched and polished to the condition of main metal. Material of jacket C polished stainless steel. Steam autoclave for clothes and options Intended use: The autoclave shall provide sterilization and drying of: - the packs with rubber stoppers for infusion solution vials;

- the packs with aluminum caps for infusion solution vials;

- clean-room clothing assemblies;

- adjustable dosing units of infusion and injection solutions filling machines;

- silicone hoses;

- Pall sterile filters;

- cassettes for ampoules dimensioned 300х300х100 mm. The autoclave shall provide drying of rubber stoppers and clothing. Residual humidity of rubber stoppers <

0.2%, Effective volume: Effective volume of chamber- approximately 1.5 m3 - the autoclave should meet the following standards requirements: ISO 11134:1994, EN 285, HTM

2010 and National Standards of Ukraine ISO Sterilization ........