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RICH-TEK participated in the ACHEMA exhibition, held in Frankfurt, Germany, from June 11 to 15, 2018.

2018-06-16 10:43

RICH-TEK participated in the ACHEMA exhibition, held in Frankfurt, Germany, from June 11 to 15, 2018.

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RICH-TEK participated in the CPHI exhibition in Shanghai, China, from June 20 to 22, 2018.

2018-06-24 10:44

RICH-TEK participated in the CPHI exhibition in Shanghai, China, from June 20 to 22, 2018.

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RICH-TEK participated in the CPHI exhibition in Shanghai, China, from June 18 to 20, 2019.

2019-06-22 10:45

RICH-TEK participated in the CPHI exhibition in Shanghai, China, from June 18 to 20, 2019.

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RICH-TEK participated in the Pharmtech & Ingredients Exhibition in Moscow, Russia, from November 19 to 22, 2019.

2019-11-25 10:45

RICH-TEK participated in the Pharmtech & Ingredients Exhibition in Moscow, Russia, from November 19 to 22, 2019.

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What are the standards for GMP cleanrooms?

2022-06-28 11:51

GMP‑compliant cleanrooms are designed to eliminate potential biological activity, dust, and contaminants, thereby fundamentally preventing any factors that could compromise the production of high‑quality products. Consequently, such cleanrooms must adhere to relevant design requirements to ensure that product quality meets regulatory standards. I. Design of the Cleanroom Structure in GMP Facilities 1. Each production stage should be seamlessly connected and facilitate effective hygiene control throughout the process, minimizing the risk of cross‑contamination. 2. In terms of layout, the sequence of processing steps must follow the product’s manufacturing flow, ensuring a smooth transition from less‑clean to more‑clean stages; cross‑contamination and backflow within the process are strictly prohibited. 3. Within the GMP cleanroom…

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Functions and Characteristics of GMP Cleanrooms

2022-06-30 16:09

As consumers’ demands for product quality continue to rise, the pharmaceutical industry and related sectors are actively striving to meet the standardized Good Manufacturing Practice (GMP) requirements. A key focus of GMP—both domestically and internationally—is maintaining a sterile, dust‑free production environment, namely GMP‑compliant cleanrooms. At present, GMP‑compliant cleanrooms have become widespread throughout China, and pharmaceutical companies adopt a cautious approach when designing and constructing such facilities. However, existing national standards do not provide specific guidance on the selection of equipment and materials in cleanroom design. For reasons of cost and technical constraints, construction firms often err on the side of conservatism and lag behind best practices, resulting in many newly built or retrofitted…

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What issues should be addressed during the rectification and optimization of GMP‑compliant cleanrooms?

2022-07-01 14:38

GMP cleanrooms are established based on the specific circumstances of pharmaceutical companies and the unique characteristics of their products. We have identified common deficiencies in GMP cleanrooms. If these issues arise, a pharmaceutical manufacturer may fail to pass a GMP compliance inspection. In such cases, the company must undertake corrective measures and optimize its facilities. 1. Unreasonable design of GMP cleanrooms. The causes of inadequate design include: first, in projects with relatively low cleanliness requirements, some contractors win bids with lower prices but cut corners during construction, resulting in substandard cleanliness; second, after construction is completed, clients introduce additional requirements or expand the cleanroom area.

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Engineering Design and Construction of GMP Cleanrooms

2022-07-11 13:42

The design and construction of GMP cleanroom projects must first divide the entire facility according to the process flow and production requirements. Such zoning should be rational and meticulous, minimizing personnel movement and preventing cross‑contamination between material flows. Whether constructing a new cleanroom or renovating an existing one, the layout must meet the following criteria: 1. Arrange equipment and workstations in accordance with the forward‑flow process to minimize circuitous paths and backtracking. GMP cleanrooms are partitioned based on process needs, ensuring a compact and streamlined configuration. The purification principles underlying GMP cleanroom engineering include: airflow filtration, high‑efficiency air handling, medium‑efficiency air treatment, fan‑assisted air supply, purified ductwork, and exhaust outlets.

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