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GMP biological purification engineering design solutions

Author: Shenzhen ZhongJian South Environment CO., LTDissuing time:2017-02-21 15:52:57Pageviews:2584smallinBig

Biopharmaceuticals require GMP to ensure the establishment of a scientific, rigorous sterile drug production environment, process, operation and management system that minimizes all possible, potentially bioactive, dusty, pyrogenic contamination, producing high Quality, health and safety of pharmaceutical products. Wha...
  Biopharmaceuticals require GMP to ensure the establishment of a scientific, rigorous sterile drug production environment, process, operation and management system that minimizes all possible, potentially bioactive, dusty, pyrogenic contamination, producing high Quality, health and safety of pharmaceutical products. What we call the biopharmaceutical purification project - GMP clean plant engineering solutions and pollution control technology is to ensure the successful implementation of GMP one of the main means;


  We have a clear understanding of the key aspects of environmental control in the biopharmaceutical production process. Energy conservation is the priority of our system solutions. We are best at giving customers the ability to comply with GMP and Fed 209D, ISO14644, IEST, EN1822 international standards, while the application of the latest energy-saving technology environment solutions; we can provide from the GMP whole plant planning and design - flow of logistics purification program, clean air-conditioning system, clean decoration system; whole plant energy-saving, , Ultra-pure gas pipeline, clean room monitoring, maintenance systems, such as a comprehensive installation of supporting services.

  Biopharmaceutical purification project-GMP clean engineering solution Description:

  I. Overview: XX company aseptic production workshop, the building is 121x18 meters, a total of three layers of reinforced concrete structure plant, single-storey area of 2268 M2. The first production workshop is located on the first floor west, the building 5 meters, the beam at the end of 4.2 meters high; which injection workshop design ceiling 3.0 meters high, the other area is 2.6 meters; raw material crushed, ingredients for 2.4 meters. The main production of sterile medical disposable appliances. Designed for 100,000 domain + air conditioning area.

  II, the design basis
  1) <Code for the Administration of Pharmaceutical Production Quality> (revised by the Ministry of Health in 1992);
  2) <Design Code for Clean Industrial Plant of Pharmaceutical Industry> (1997)
  3) <Guidelines for the Implementation of Pharmaceutical Production Management () (1992)
  4) Code for Design of Clean Buildings (1984)
  5) <Design rules for heating ventilation and air conditioning> (GBJ19-87)
  6) <sterile medical equipment production management practices> (YY / T-0033-90)
  7) <Party A to provide the process plan and other relevant technical information;


  III, The regional distribution:
  production workshop according to the production process and product quality requirements, divided into general production areas, control areas and.
Set the staff for the shoe area, men and women one or two dressing room, hand washing, hand disinfection, laundry room, air shower channel, clean flow corridor, logistics cargo shower walkway, injection molding, pad blowing dust, Within the packaging, packaging and room, logistics and so on. The room is located in the third floor of the day surface of the small room, need to do noise shock treatment; cooling towers and cooling pump placed on the third floor of the day; equipment operating load to meet the floor load requirements.

  IV, The direction of flow of people:
  changing shoes, changing clothes, hand washing, hand disinfection - air shower channel - clean corridor - clean workshop; in the purification workshop and corridor security door, easy evacuation.
Item Flow direction: Logistics channel ------ clean workshop -------- finished packaging

  V, clean air conditioning system:

  A)Weather data: summer air conditioning: 33 ℃ / winter ventilation: 14.1 ℃
  B)Summer outdoor ventilation: 27.9 ℃; relative: 83%; summer ventilation relative: 70%; winter air conditioning: 5 ℃ winter air conditioning relative: 72%;
  C) iInterior design parameters:
  1) workshop field 10 million, a total of 2160 M2,
  2) pressure: clean workshop to maintain a positive pressure, and outdoor static 10Pa
  3) 18 to 26 ° C;
  4) 50 to 65%;
  5) air flow organization: a. On the station to the lower side of the column back to the wind, then the return air to the engine room; three filtration system;
  6) the amount of fresh air to ensure that the pressure requirements and personnel without discomfort, to ensure that the amount of fresh air> 40 M3 / h.

  VI,plan description
  1): design total cooling 115USRT, to be selected 5 YORK water-cooled air-conditioned cabinet units, each with a new Ling cooling tower, and a cooling pipe pump. Cooling towers and pumps located in the second floor of the sky and the nearest distance from the unit, the water cabinet and set up in the workshop room, combined into a clean air conditioning system.
  2): clean air conditioning return air system, with the cabinet and the combination of cooling and dehumidification (table cold), the new return air mixing, pressurization, early, two filters and other treatment process, the end of the filter device (indoor ceiling ).
  3): According to the process layout requirements and the actual situation set up five clean air supply system and four exhaust system:
  A. ①-③ shaft, front area preparation area and buffer isolation area, area 144 M2, 2.6 m; set J-1 purification air supply system and P-1 exhaust system. Other front area (one more and wash hands) set comfort air conditioning air.
  B. ③-⑥ axis, injection + extrusion workshop, due to equipment to produce large dust to do local exhaust; and add fresh air to   maintain the workshop positive pressure. Set the J-2 air supply system, the cold load by the amount of fresh air to add; set the exhaust system P-2 (local strong exhaust). The area is 3 meters.
  C. ⑥-⒃ axis, the reservoir, fine washing, rough washing and assembly workshop, more personnel, the new air volume per person> 40 M3 / h and maintain the maximum amount of room pressure to take the value; set J-3 / J -5 four air supply system, P-3, P-4 exhaust system. The area is 3 meters.
  4): As a result of Party A clean room clearance to ensure that the height of 3 meters, the largest ceiling of the ceiling can only do 400mm, the engine room located in the С-axis, the main road to avoid the beam, branch evenly distributed to the wind End air supply.
  5): clean air conditioning system duct material using high-quality galvanized steel, when the rectangular air duct long side b (mm): 100
  6): In addition to fresh air and exhaust pipes, the duct are required insulation. Thermal insulation materials with aluminum foil glass wool felt: 24K / δ = 25mm;


  VII, Purification plant decoration
  1) smallpox: inside with excellent insulation, clean and bright, the color with gray or Party selected, thick 50mm; other non-as the reservoir area, into the factory before the district, the packaging area to do light gray aluminum metal bones, Mm, 600X600.
  2) interval: double-sided color steel insulation board enclosure and spacing, Wai Wai to the ceiling; clean corridor and workshop interval to do through the aluminum alloy half-windows, windowsill height 900mm, glass thickness 8mm, 1200mm high, glass Window high flat door height (2100mm); aluminum alloy window with a special purification material, 45 degree bevel edge, and the ground and the ceiling angle to do arc and Yin angle interface, in line with the specifications and health disinfection requirements.
  3) closed door: 800X2100, do the glass observation window, loaded ball-type channel lock.
  4) the ground: the original cement floor to be treated after the epoxy resin EPOXY surface layer, injection molding thickness of 3mm epoxy quartz mortar, wear and tear; other thick 0.5mm epoxy layer; color for the apple green or by a Square selection. Clean and clean, easy to clean, engage in health, no dust bacteria. Or ground materials and treatment methods selected by the Party.
  5) pillars: pillars with full wrapping.
  6) control area and non-control interval made of double-layer structure, control area made of single-layer structure, with the production. Assembly between the packaging and packaging made of channel type. With dark cover light room 40WX2, work area> 250Lux, walkway> 100Lux; purification between the set of UV germicidal lamp, and lighting design. With iron wire tube. Comply with fire and electricity specifications.

  VIII,Lighting, distribution:
  The specific size of the scene and the technical staff to determine.

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