WOL undertakes the planning and construction of traditional Chinese medicine clean workshops

Core Design and Construction of Traditional Chinese Medicine Clean Room and Wolin Practice

The core of the design and construction of a traditional Chinese medicine clean room is to create a production space that strictly adheres to GMP general standards and fully adapts to the characteristics of traditional Chinese medicine and the special process of traditional Chinese medicine. As a Guangzhou Wolin Laboratory that has been focusing on the field of clean engineering for many years, we have summarized this core in practice as follows: risk control as the guide, process flow as the main line, and achieving a deep combination of standardization and characteristics.

1、 Core design philosophy: Originating from standards, achieving customization

In years of practice, Guangzhou Wolin has always focused on three core concepts in the design of traditional Chinese medicine workshops:

1. Principle of process adaptation: The design starts from serving the processing, extraction, formulation and other processes of traditional Chinese medicine, rather than simply replicating drug templates. For example, in response to the high humidity and high heat characteristics of the extraction area, we focus on strengthening the design of corrosion-resistant and strong moisture removal systems.

   
   

2. Pollution prevention and control principle: Making the prevention of cross contamination the core of the layout. We have designed scientific personnel separation, clean zones, and pressure gradient, and set up independent treatment rooms and capture facilities at the source for common sources of pollution such as dust, odors, and microorganisms in traditional Chinese medicine production.

   
   

3. Quality traceability principle: Designed to provide a hardware foundation for the entire process quality control. The flow from the medicinal herb warehouse to the finished product warehouse is clear, and data interfaces are reserved at key process points to create conditions for establishing a digital traceability system from medicinal herbs to finished products.

2、 Key areas design focus

Based on the above concepts, the design of each functional area needs to address its contradictions:

1. Pre processing and processing area for medicinal herbs: This is the characteristic and risk starting point of traditional Chinese medicine production. The core lies in isolation and collection. Wolin Design regards it as an independent area, setting up dedicated rooms for dust and gas production processes such as crushing and frying, and equipped with efficient local dust removal and exhaust gas treatment devices to ensure that pollution does not spread to the clean area.

2. Extraction and concentration zone: facing challenges of high humidity, corrosion, and cleaning. The design focuses on the selection of corrosion-resistant materials, high-power dehumidification systems, and clean and washable design of equipment and pipelines to prevent cross contamination caused by residual chemicals.

3. Preparation clean area: It is the core to ensure the cleanliness of the final product. We strictly follow the requirements of Class D or higher cleanliness level, and accurately control the temperature, humidity, pressure difference, and cleanliness between various functional rooms through a reasonable layout and intelligent air conditioning purification system. We adopt a design of negative pressure isolation and front chamber buffering to effectively control dust.

4. Storage and logistics system: The core design is to prevent confusion and errors. We plan strict storage and zoning management, set up physical isolation warehouses/counters for toxic and precious medicinal materials, and design clear, one-way logistics channels to prevent cross contamination.

3、 Professional implementation guarantee of Wolin

With years of accumulation in the field of biopharmaceutical cleanliness, Guangzhou Wolin provides systematic support for traditional Chinese medicine projects

1. Forward looking compliance design: We have been deeply involved in the early stages of design, integrating regulatory requirements such as Chinese GMP and the 2023 version of the "Quality Management Standards for Traditional Chinese Medicine Production" into the blueprint to avoid later modifications and help enterprises efficiently pass certification.

   
   

2. Specialized engineering solutions: We have rich experience in handling engineering problems such as dust removal, dehumidification, anti-corrosion, and odor control in traditional Chinese medicine production, and can provide targeted solutions.

   
   

3. Full cycle professional services: From process requirement analysis in the early stages of the project, to professional implementation of clean engineering in the construction phase (with qualifications in building decoration, mechanical and electrical installation, etc.), to system validation (DQ/IQ/OQ/PQ) and document system support before delivery, we provide one-stop services to ensure that the workshop meets the predetermined quality objectives from construction to operation.

Conclusion

In summary, a professional Chinese medicine clean room is a key infrastructure for achieving modernization and standardized production of Chinese medicine. The core value of Guangzhou Wolin lies in its deep understanding of GMP standards and practical grasp of traditional Chinese medicine processes, integrating compliance requirements, production characteristics of traditional Chinese medicine, and engineering practices to create a safe, compliant, efficient, and high-quality production environment tailored for customers, laying a solid hardware foundation for the stability and reliability of traditional Chinese medicine products.

WOL undertakes the planning and construction of traditional Chinese medicine clean workshops

WOL undertakes the planning and construction of traditional Chinese medicine clean workshops