Selecting the Right Clean Room 建设 Materials

作者:Scott A. Kouri, PortaFab Corporation and 雷蒙德·K. 施耐德,P.E.克莱姆森大学

The question of modular versus conventional clean room construction is increasingly common in high-tech industries, and one that may have a different answer depending on each individual project. 速度推向市场, 然而, is critical for almost all manufacturing companies, and it’s particularly important for the pharmaceutical and biopharmaceutical industries, which need to maximize the patent protection period after what is usually a long and expensive product development cycle. It’s also crucial for the microelectronics industry where technology changes on a near-daily basis.

设施的设计和建造也具有最大的适应性,并提供最小的操作中断或停机时间. In order to meet this need, 设施的组成部分不仅要允许变化,而且要在市场需求变化时提供最大的灵活性. 前进, 充分理解项目的需求,并将所需的功能需求(must-have)与美学偏好(nice-to-have)分开是很重要的。. 本文将探讨确定最高效、最经济的洁净室施工技术的关键选择标准, with a particular emphasis on the potential benefits offered by modular construction.


clean room construction

建设 Site Factors

建设 activities invariably result in disruption to areas surrounding the construction site. 例如, 尘一代, 增加人员, 噪音和振动, access restrictions and accidental damage can negatively impact any job site. 制药和半导体设备对传统建筑产生的灰尘和碎片特别敏感, which can be carried by personnel into other areas or drawn into ventilation inlets.

Availability of skilled labor is another consideration. 坚持建设预算可以很大程度上受到劳动力不稳定和建筑材料的可用性差的影响. 例如, after hurricane Katrina, resources for sheet rock were scarce since all available materials were being purchased to rebuild affected areas. And, constrained laydown areas can also be a challenge. Lack of storage space can potentially delay the build process and impose additional costs.

Project Schedule and 成本

Whenever a new product introduction requires a new purpose-built facility, construction must be carried out as quickly as possible. One way to reduce construction time is to perform as many construction activities in parallel as possible. This might entail, for example, installing chase walls together with process and utility lines.

Project costs and economics can be assessed in two ways: cost assessment-costs of the actual construction; and financial assessment-benefits derived from the speed of construction and improved cash flow.

Table 1: 成本 estimate per ft2 installed

 

在一般情况下, 与传统建筑材料相比,用于模块化建筑的建筑材料更昂贵(见表1)。. 尽管模块化结构最初比传统结构更昂贵(成品干墙平均每平方英尺10到12美元),并且可以使用现成的材料建造, the disadvantages can sometimes outweigh these attributes. 例如, conventional construction is permanent, making modifications to any room expensive, messy and disruptive to the current operation. Existing walls cannot be reused and require new materials and labor, increasing renovation costs. There are also no tax advantages associated with this type of construction.


Regulations and Standards

Any construction project, whether cleanroom-related or not, is subject to building codes. Regardless of construction technique, the overall objective of a building project is the same. 洁净室设施的组成部分必须满足地方和国家建筑防火和结构设计的规定. 材料要求满足最小火焰和烟雾发展要求(A级不可燃物)或有防火隔离墙(危险区域防火1- 2小时).

洁净室和受控环境中使用的建筑饰面设计指南可以根据房间的分类而不同, 房间的使用, and product manufacturing. Therefore, finishes should be carefully evaluated for specific compliance. 建筑饰面必须满足建筑法规要求,并应附有书面文件和认证的测试数据,以验证符合性. Applicable testing may include ASTM E84 Flame Spread and Smoke Development Values.

As part of the overall design, architectural systems and finishes should meet project-specific 健康 and 安全 requirements, state and/or local building codes, and local seismic codes. 建筑系统还应该有能力通过公用事业追逐或不锈钢公用事业板集成工艺设备和工艺公用事业.

洁净室设施通常被分为两种不同的占用类型:F(工厂和工业)和H(高风险). 除了 to adopting major codes and procedures, most jurisdictions write amendments to the model codes to adapt them to local needs. 设计师应熟悉通用规范的要求,并修改当地规范,以确保所有适用的规则都已找到. Engineering design guides can assist in the design and the planning of cleanrooms and controlled environment areas. These sources include FDA guidance documents, United States Pharmacopeia (USP), 欧洲法规, and industry guidance documents (e.g., ISPE Baseline Guides®, and IEST guidelines).

Very few industries are as highly regulated as the pharmaceutical industry. 事实上, because the industry is so regulated, 这不是不常见的, when a certain methodology works for a facility, for an “if it’s not broken, why fix it” mindset to develop. 只要有可能, quality should be designed into the facilities to avoid any adverse impact on the product itself. Although other industries may not be subject to such strict regulation, the quality standards are no less critical to the operation.

 

The Case for 积木式结构

Modular clean room construction can offer a number of important advantages over conventional (stick-build) approaches. 例如, modular walls are an inherently dry construction material with little or no modification required for installation, thus minimizing 尘一代. Modular systems can also be manufactured from materials that are non-shedding and non-particulating.

Since modular construction creates little dust, a “clean build” approach can be taken by installing other critical processes along side it. Fit-outs can be cut into panels at the same time as the erection of the system, reducing the project schedule. For less complicated non-pharmaceutical projects, it has been shown that modular construction can reduce construction time by 20 to 40 percent through parallel construction. 除了, modular construction greatly enhances facility clean-up post-construction.

Modular construction can also offer a solution to a lack of skilled labor in any given market. Modular walls are manufactured to provide a consistent quality, 根据工人的技术水平,在洁净室的一个部分到另一个部分的传统结构中,哪些会有所不同. Since modular construction is prefabricated, 模块化系统制造商和承包商还可以协调项目进度,并根据在建设施的部分分期发运建筑材料. As that section is being built, the next group of materials can be staged and shipped to coordinate with the completion of the previous installation.

Although modular walls are more expensive up-front, costs can be offset by the savings achieved through greater productivity. 例如, 由于对标准建筑尺寸和组件预制的依赖,模块化建筑可以减少建筑材料的浪费. Since materials are pre-engineered and cut to size at the factory, in many cases on-site cutting of materials can be completely eliminated. 除了, 在大多数情况下,模块化结构可以被视为一种设备,因此会受到加速折旧和税收方面的考虑.

Modular construction also offers advantages for meeting 监管要求 and standards. Modular wall systems are manufactured with factory-controlled procedures, 产生一个一致的, quality product with no variation. 这确保了在一个设施中成功使用的材料在未来的安装中也能发挥同样的作用。材料也必须以一种固定的方式安装, 产生一个一致的 appearance.

预制墙体系统结合了当前工程指南中概述的原则,并将其应用于洁净室的设计和施工. 电子竞技游戏已经纳入了遵循良好工程实践的系统性能设计标准, 考虑到GMP, 环鸟苷酸, 安全, 健康, 监管要求, 和行业准则.

Modular design also accommodates the need for flexibility. 例如, 采用可拆卸墙体的非连续施工,可以在不影响相邻墙体的情况下拆卸单独的墙体板, 地板或天花板. 除了, modular systems can be disassembled and modules can be relocated to quickly create or expand cleanrooms, lowering the costs of expanding existing pilot plants or low-volume launches to high-volume operations.

Modular wall systems can be designed with access panels into the chases. Full-size panels can also be easily removed to access larger openings into the chases. 模块化面板系统允许业主和承包商在安装过程中进行现场修改, offering additional installation flexibility and potential design cost savings. 使用标准组件的能力通过降低设计成本和提高施工可预测性提供了经济节约.

Customers can buy or lease modular cleanrooms, which are considered a piece of equipment, not a part of the existing structure. This means significant financial advantages because they can be depreciated at an accelerated rate. For a company leasing space, a modular room remains the property of the lessee, while any conventional construction would remain with the space and be the property of the lessor.

Flexibility remains a key design option in the use of modular architectural systems, as well as the ability to incorporate only those materials that best suit the project scope and 设计要求. Pre-engineered modular architectural systems for cleanrooms and critical environments can offer owners, 架构师, 工程师们在建造替代方案和灵活性的同时,保持专业洁净室环境所需的设计标准和监管指南.

结论

项目范围, 设计要求, manufacturing processes, 施工进度都是考虑和选择洁净室环境施工材料的因素. 材料选择审查过程将确保材料符合特定制造工艺的设计要求,并且这些材料符合公认的设计和法规指南.

 

斯科特Kouri is sales manager for PortaFab (Chesterfield, MO).

雷蒙德·K. 施耐德,P.E., is the Interim Chair of the Department of 建设 science and Technology at Clemson University.

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