CN210086919U

CN210086919U - GMP workshop with figure flow dual vertical through layout

Info

Publication number: CN210086919U
Application number: CN201920580336.8U
Authority: CN
Inventors: 张新晴; 蔡进
Original assignee: Tianjishi Engineering Technology Group Co Ltd
Current assignee: Tianjishi Engineering Technology Group Co Ltd
Priority date: 2019-04-25
Filing date: 2019-04-25
Publication date: 2020-02-18
Anticipated expiration: 2029-04-25

Abstract

A GMP workshop with figure flow double vertical through layout relates to a layout for a GMP workshop. The GMP workshop is simple in structure, low in cost and simple and convenient in design. The utility model discloses a design method includes and adopts the perpendicular overall arrangement of commodity circulation to make each GMP workshop become upper and lower floor and construct with the commodity circulation, then sets up the personnel passageway between each room of the same clean rank on different layers to constitute each hierarchical clean region, set up the system of changing clothes respectively in every hierarchical clean region. On the basis of meeting basic requirements of GMP (good manufacturing practice) specifications, the problem that personnel waste or repeated changing of the same operator caused by respectively changing the clothes of the same clean-level personnel on the upper layer and the lower layer when the logistics of a GMP workshop is vertically distributed is solved. The achievement enables operators in the clean area to conveniently enter the upper layer and the lower layer, the quantity of workers in the clean area can be reduced, unnecessary clean changing area is reduced, and production energy consumption is reduced.

Description

GMP workshop with figure flow dual vertical through layout

Technical Field

The utility model relates to a GMP aseptic purification workshop field especially relates to a double GMP workshop that link up the overall arrangement perpendicularly of personage stream.

Background

A gmp (good Manufacturing practice) workshop is a production workshop capable of realizing internal purification, and is widely applied to various industries, particularly to the industries of medicine, food and the like.

On the one hand, the regulations in the "quality management of pharmaceutical manufacturing code (revised 2010)", (hereinafter referred to as "GMP in china") stipulate that "residues of the same intermediate product or crude drug are carried into subsequent batches and should be strictly controlled. The residues brought in must not introduce degradants or microbial contamination nor adversely affect the impurity profile of the drug substance. "accordingly, it is important to reduce the residue of the medicine in the equipment and piping and to facilitate cleaning and sterilization. And the mutual transfer of materials among the devices arranged at the same height is easy to cause residue, thereby being easy to cause pollution. Therefore, materials are transferred among the devices in a gravity-flow mode, and the design method of the logistics vertical layout of the medicine production line is developed.

On the other hand, the requirement of "personnel changing the clothes passageway entering the clean production area" in the GMP and its guidelines in china should be set up with corresponding clothes changing facilities according to the production properties, product characteristics, the requirements of the product to the environment, etc., and reasonably design the air flow organization, set the pressure difference and monitor device to meet the requirements of GMP for purifying and changing clothes. "dressing programs generally include: changing shoes, taking off outer coat, washing hands, wearing clean clothes (including aseptic underwear and aseptic outer coat), sterilizing hands and the like. "

Based on the two aspects, new problems appear after the vertical layout of logistics is adopted, namely: the upper and lower clean areas all need personnel to operate, and personnel pass in and out the clean area and all need pass through the system of changing clothes, so need the upper and lower floor be equipped with operating personnel respectively or same operating personnel change clothes repeatedly to in process of production, caused personnel's waste or produced a great deal of problems such as inconvenient operation. For this reason, improvement from the design method is required.

SUMMERY OF THE UTILITY MODEL

The to-be-solved technical problem of the utility model is to provide a double perpendicular overall arrangement GMP workshop that link up of personage stream simple structure, with low costs, easy and simple to handle.

Therefore the utility model discloses a GMP workshop people commodity circulation dual perpendicular link up design method of overall arrangement, this method adopt commodity circulation perpendicular overall arrangement to make each GMP workshop become upper and lower floor and construct with the commodity circulation, then set up personnel's passageway between each room of the same clean rank on different layers to constitute each rank clean region, and set up the system of changing clothes respectively in every rank clean region, in order to design into a GMP workshop that has the dual perpendicular link up overall arrangement of people stream. On the basis of meeting basic requirements of GMP (good manufacturing practice) specifications, the problem that personnel waste or repeated changing of the same operator caused by respectively changing the clothes of the same clean-level personnel on the upper layer and the lower layer is solved while the vertical layout of logistics is adopted in a GMP workshop.

Wherein: the workshops of the same grade on different layers can be connected by adopting a clean steel ladder.

Therefore the utility model provides a dual GMP workshop that link up overall arrangement perpendicularly of personage stream adopts the perpendicular overall arrangement of commodity circulation, and each clean level room becomes perpendicular multilayer respectively and lays, and each clean level difference has a system of changing clothes respectively, and is equipped with between each room of the same clean level on different layers and link up the personnel passageway perpendicularly and be connected to constitute the perpendicular personage stream region of each corresponding rank.

Furthermore, the vertical through personnel passage is a clean steel ladder.

Further, the changing system is designed at the upper layer or the lower layer according to the comprehensive consideration of the actual situation, so that an operator can change clothes into a clean area from the changing system and can directly pass through a clean steel ladder to reach another layer needing to be operated.

The utility model discloses an among the design method of the dual perpendicular overall arrangement that link up of GMP workshop people commodity circulation, carry out design optimization to the GMP workshop production line of the perpendicular overall arrangement of commodity circulation, the upper and lower floor of the perpendicular overall arrangement of better solution commodity circulation GMP workshop production line all need the upper and lower floor be equipped with operating personnel respectively or same operating personnel changes the clothing repeatedly, causes the extravagant or inconvenient scheduling problem of operation of personnel for the production process. On the basis of meeting the basic requirements of GMP (good manufacturing practice) specifications, the problem that personnel in a clean area can conveniently enter an upper layer and a lower layer when the logistics of a GMP workshop are vertically distributed is solved. The achievement can reduce the quantity of workers in a clean area, reduce unnecessary clean changing area, reduce production energy consumption and have practical value in the design field of a GMP workshop.

The design method of the double vertical through layout of the man-material flow in the GMP workshop according to the present invention will be further described with reference to the accompanying drawings.

Drawings

FIG. 1 is a block diagram of a process flow of an aseptic crystallization line according to an embodiment of the present invention;

fig. 2 is a process equipment layout and clean zone division diagram of an aseptic crystallization production line designed by the design method of GMP workshop human and logistics dual vertical through layout.

Wherein: 21 is a clean steel ladder which is communicated up and down.

Detailed Description

The clean area of the upper and lower floor in order to solve the perpendicular overall arrangement of commodity circulation GMP workshop production line all needs personnel to operate, therefore the existence all need pass through the system of changing clothes because of personnel business turn over clean area, so need upper and lower floor be equipped with operating personnel respectively or same operating personnel changes clothes repeatedly, causes the extravagant or inconvenient scheduling problem of operation of personnel for the production process. The utility model discloses GMP workshop production line to the perpendicular overall arrangement of commodity circulation carries out design optimization, better solution this problem. On the basis of meeting the basic requirements of GMP (good manufacturing practice) specifications, the problem that personnel in a clean area can conveniently enter an upper layer and a lower layer when the logistics of a GMP workshop are vertically distributed is solved. The achievement can reduce the quantity of workers in a clean area, reduce unnecessary clean changing area, reduce production energy consumption and have practical value in the design field of a GMP workshop.

A design method of double vertical through layout of GMP workshop human logistics is used for design optimization of GMP workshop production line with vertical logistics layout, and the basic concept is explained as follows:

1. the utility model discloses on the GMP workshop production line of the dual perpendicular overall arrangement that link up of personage stream, not only the perpendicular overall arrangement design of commodity circulation, the design also link up perpendicularly of personage stream moreover.

2. Clean areas of the same clean level on the upper layer and the lower layer can share one people stream changing system, and clean steel ladders are adopted inside the clean areas to be connected up and down.

3. The people flow dressing system is designed on one layer only, operators can enter a clean area for dressing, and the other layer can directly reach the clean area through a clean steel ladder when needing to be operated.

In addition, the people stream dressing change system can be designed on the upper layer or the lower layer, and is comprehensively considered according to actual conditions.

4. The cleanliness class of a GMP plant may be class B, class C or class D.

In order to further understand the gist of the present invention, a detailed description of the present invention is given below with reference to a specific embodiment.

FIG. 1 shows a block diagram of a process flow for an aseptic crystallization line. The aseptic crystallization production line mainly comprises the steps of dissolving, matching, decoloring, filtering, crystallizing, filtering, washing, drying, crushing, mixing powder, subpackaging and the like. Wherein, the dissolving, the decoloring, the clean grade of the filtering room is grade C, the crystallization, the filtering, the washing and the drying, the powder mixing and the room split charging are grade B. If at least four dressing systems are provided, as is customary, this is not only wasteful of space but also increases the number of personnel.

Therefore, can adopt the utility model discloses a design method that GMP workshop people commodity circulation is dual link up the overall arrangement perpendicularly designs:

as shown in fig. 2, a process equipment layout and clean zone partition diagram of an aseptic crystallization production line according to an embodiment of the present invention adopts a dual vertical through layout of human logistics in class B and class C clean zones.

The clean grade of a room subjected to dissolving, matching, decoloring, filtering and aluminum barrel cleaning and sterilization is grade C, and the clean grade of a room subjected to crystallization, filtering, washing, drying, powder mixing and subpackaging is grade B. Wherein, the procedures of dissolving, matching, decoloring, filtering, crystallizing, filtering, washing, drying and mixing powder are positioned on the upper layer of the vertical layout, and the procedures of cleaning, sterilizing and subpackaging an aluminum barrel are positioned on the lower layer of the vertical layout.

Logistics: dissolving and decolorizing the raw material medicines in a dissolving and preparing tank, filtering by a filter, and then crystallizing in a crystallizing tank; discharging the crystallization liquid from the bottom of the crystallization tank to a three-in-one machine for filtering, washing and drying; discharging the materials by the three-in-one machine, and vacuumizing the crushed solid materials to a powder mixer for mixing the powder; the mixed powder solid material automatically flows to a racking machine at the lower layer by gravity and is packed into an aluminum barrel; and (5) rolling and covering the cover, and then delivering the finished product out.

People flow: c level personnel get into C level clean district at lower floor's change clothing, can carry out operations such as aluminium bucket washing on this layer, need go up the upper strata to the clean steel ladder that dissolves the regional operation of joining in marriage decoloration through C level clean district. B level operating personnel get into B level clean district at lower floor's change clothing, can carry out the partial shipment operation on this layer, need go up the upper strata through the clean steel ladder of B level to the personnel of the regional operation of crystallization.

The arrangement of the clean steel ladder realizes the function that people in the upper layer area and the lower layer area of the same clean area can conveniently enter the clean steel ladder.

The above-mentioned embodiments are only for describing the preferred embodiments of the present invention, and are not intended to limit the scope of the present invention, and various modifications and improvements made by those skilled in the art without departing from the design spirit of the present invention should fall into the protection scope defined by the claims of the present invention.

Claims

1. The utility model provides a double GMP workshop that link up overall arrangement perpendicularly of personage stream, adopts the perpendicular overall arrangement of commodity circulation, and each clean level room becomes perpendicular multilayer respectively and lays its characterized in that: each cleaning level difference is provided with a clothes changing system, and each room with the same cleaning level on different layers is provided with a vertical through personnel passage for connection so as to form a vertical people flow area of each corresponding level.

2. The GMP plant according to claim 1, wherein the GMP plant is configured for dual vertical cut-through of people flow: the vertical through personnel passage is a clean steel ladder.

3. The GMP plant with a dual vertical cut-through arrangement for people flow according to claim 1 or 2, characterized in that: the changing system is designed at the upper layer or at the lower layer according to the comprehensive consideration of the actual situation, so that an operator can change clothes into a clean area through the changing system and can directly pass through a clean steel ladder to reach another layer needing to be operated.