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The Coltea Clinical Hospital Project

Clean Room and Ventilation System part of Hematology Ward, Hematopoietic Stem Cells Transplantation Department



Overview

Clean room is an environment with low levels of polluting factors that can conduct under safety rules and carefully controlled pre - level of contamination is fully supervised. In a clean room air is constantly filtered to remove particles and impurities that can harm activity in specific areas.
Clean room is a room where the concentration of airborne particles is controlled and which is constructed and operated so that the introduction, generation and retention of particles to be minimal and relevant parameters (temperature, humidity, pressure, speed) in accordance with national and international standards (Europe - ISO 14644 and ISO 14698).
Fitting cleanroom accessories are made with a specially furniture created for this type of modulating their rooms, perfect tightness and ensure a high possibility of cleaning and maintenance.

Technical Description

a) design theme and execution, body building B1, et. 1:

1. The first 6 rooms from body N becomes "section graft transplant stem cells sectional Hematology", turns in rooms with special status of cleanrooms ISO 14644, and is structured as follows:
• lounge access - dressing (standard ISO 9)
• doctor's office (ISO 8)
• chamber sterilization (ISO 8)
• salon patients, pre / post transplant (ISO 8) with the following features: console with outlets oxygen, sterile air, vacuum, monitors, electrical outlets for bed infuzomate and automatic syringes; support for monitor + socket supporting cable TV, network, telephone, transmission system monitors information from the nurses to the center console, internal communication system with nurses;
• nurses (ISO 8) with the following features: console tracking patient monitors; mains socket for connection to the hospital network, the Internet; telephone sockets, fax; cable TV outlet; System communication with patients (alert system call nurses);
• preparation chamber infusion solutions (ISO 8), with the following equipment: chemical hood (flow rate 485 m3 / h, consumption 0.65 kw);
• patient room X 2 (ISO 7) with the following features: console with outlets for oxygen, sterile air, vacuum, monitors; electrical outlets for bed infuzomate and automatic syringes; support for monitor support, infuzomate, injectomats + cable TV outlets, network, telephone, transmission system monitors information from the nurses to the center console, internal communication system with nurses;
• SAS moves / cloakroom (ISO 7): the shift toward patients' rooms presents a locker room acting as additional buffer that is to be equip with protective equipment cabinets;
• 3 + nurses' patient rooms will be equipped with individual bathrooms with these sanitary ware: wash basin, shower, toilet bowl; sinks and showers will be equipped with a separate water circuit, circuit that will run through a special purification stations NORIT type;
• hallway / dressing (standard ISO 9) - general access cleanroom area will be from N body through a hallway locker buffer role for both staff and patients;

2. Connects cleanroom HVAC system for the hospital's BMS (Building Managememt System - command and control system for a building environment);
3. It makes equipping VIP room on the 1st floor B1 body and all rooms on the ground floor B1 body with fan ventilation system.

b) technical solution

Architecture:

Making cleanroom consists in wall cladding of existing drywall with galvanized steel sheets with thickness of 0.8 mm in width 1200 mm vertical bands electrostatic painted in RAL colors. Steel sheets are mounted with self-adhesive tape or polyurethane adhesive. All joints are covered / sealed with silicone. Connecting to the floor is by cavet. HVAC distribution system is placed above the false ceiling. Openings for control panels are cut into partitions construction. All connections are covered / sealed with silicone culorare corresponding RAL.
Technical ceiling is made at the rate of 2750 mm fromthe floor panels (cassettes) standard size 1200x600 mm, backed by an anchor made of special profiles. Ceiling lights are intergrate specific size 1200x600 mm, extension filtration and vacuum and / or laminar flowunits. The link between the ceiling and walls is by cavet. To ensure natural lighting in the windows of the building integrates into existing drywall walls glazing (window panels) with integrated blinds.

HVAC (ventilation and air conditioning - clean rooms)

Ventilation and air conditioning system consists of:

1. Central for treating air with the following modules:

- reception room air frame opposite blinds operated actuator;
- The coarse filter EU 5;
- The intermediate heat recovery agent (air / glycolic);
- Heating mode air - electrical resistance 3 power;
- The cooling / heating - DX, ecological R410A freon intermediary agent.
- The air supply centrifugal fan;
- Muffler - mounted after the fan is to reduce the sound pressure level in circuit piping - EU7 fine filter module raise class air filtration, leading to the final filters EU14 protection of technical rooms.
- How EU7 fine filters, which allow withholding any technical space particles - in the outlet;
- The intermediate heat recovery agent (air / glycolic) - in the outlet;
- Centrifugal air exhaust fan module ester variable speed and constant pressure allows maintenance in the system - in the outlet;

2. The group compressor / condenser coolant / heating was conducted in two independent units. During the winter one of them working in parallel with the other two sources of production of thermal energy (heat recovery and electric heater). During the summer, two units (modules) are working in parallel to produce the necessary energy from the evaporator air handling units.
3. switchboard and automation that was connected to the BMS system Hospital corners was designed to fly entire air-conditioning system / ventilation; it is composed of both digital program and all the control in the field, actuators, solenoid valves, differential pressure switch, frost protection sensors, sensors and alarms for faults.
4. ventilator for the "toilets" was staged in the technical space above the 1st floor operation is driven by the control panel and automation of Central air handling, so consumers required steps to maintain pressure permanently constant. On the outlet was fitted with blades way valve and gravity grid.
5. Exhaust air fan for the sterilization space, SAS and solution preparation room and other facilities fitted as in technical areas above floor 1. And this fan is piloted by the control panel and air treatment plant automation for the same reason to maintain the pressure in steps (depending on the grades of cleanliness required ISO7, ISO 8 and ISO 9).
6. The air distribution channels was made of special pieces of ALP (aluminum double fireproof polyisocyanurate plated with aluminum foil) with embossed smooth surface inside and outside. Sandwich thickness is 20 mm.
7. filtration system and air diffusion was achieved through compact. They sealed their structure mounting box filter, HEPA H14, speaker and air flow control flap. Tight box is made of lacquered steel sheet with circular connection spigot and socket for measuring the differential pressure of the final filter. H14 HEPA filters were sealed in boxes mounted by fastening systems and bracing with clamp. The flap air flow control enables pressure balance within each camera. Type diffuser is swirled and was erected at the ceiling.

HVAC (ventilation and air conditioning - areas related to cleanrooms)

The building is equipped with a DX cooling system with variable refrigerant flow. It consists of indoor units and concealed box type (type "duct"), a module oftwo outdoor units, systems and branch distribution freon pipes that will link the indoor and outdoor units. The units of "duct" are located in the false ceiling of each room and are connected to each served two air inlet or outlet grille / air circulation. The air conditioning system chosen for the surround cleanroom is dimensioned to support climate parameters during the summer by air recirculation (without fresh air), but he also works during the winter as a supplementary heat source in case of damage that may occur to theheating system with existing state bodies.

Wall Brackets and medical gases

Wall brackets are located so that access to terminal units for attaching accessories you can clearly and electrical cables do not impede the movement of medical personnel or medical equipment around the bed of the patient. The brackets were fitted with direct lighting (200 W per patient) and indirect (36 W fluorescent lamp). To monitor the pressures of medical gas installations and alarm if they are not in the parameters provided an array that allows total closure of the medical fluid supply downstream in case of emergency or service interventions. The entire installation of medical gas pipes was made of copper distribution medically tested and plugged at both ends according to SR EN 13348. They also are marked with European EN 13348 and CE marking.

Ultrapure Water Filtration

It was installed a complex system based on microbial filtration ultrafiltration membrane technology that ensures that no pathogens in drinking water. The filtration system is configured as follows: on the one hand, filter pretreatment to retain particles larger than 50 microns from the feed water (central unit) and on the other hand, duplex ultrafiltration to ensure water supply microbiologically pure each washer / washers and each of showers.

d) Implementation / duration of the entire work, starting with the project, continuing with production and ending with the installation components and all components are made in full compliance with the beneficiary - Coltea Hospital. The total duration of the execution of the work was extremely short, commissioning of the system "inside the clean room ventilation system and hematology ward, hematopoietic stem cell transplant department" achieved in only 90 days from the date of contracting.

Validation / qualification

Validation / qualification / certification is an activity essential for the future development of the activity has been designed for clean room and serves conditiior work and equipment certification according to the regulations in force. Depending on the specific activities to be held in clean room validation should be done or not according to GMP (Good Manufacturing Practice). GMP is a term that defines globally recognized control and management of manufacturing and quality control testing of foods, pharmaceutical products and medical devices.
The qualification is an operation which demonstrates that the equipment works properly and lead effectively in the expected results and validation demonstrate that any procedure, process, equipment, material, activity or system drive real results predetermined in accordance with the principles of good practice. The paper 'premises clean and hematology ward ventilation system, hematopoietic stem cell transplant compartment "was achieved full validation project, including design qualification, installation qualification, operation qualification, performance qualification and classification software.


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