# 二类Medical DevicesGMP车间Construction:Huajian Jing以硬核Strength筑牢品质防线
In the medical device industry; Clean "; Two words are more important than Mount Tai. Class II medical devices come into direct contact with the human body, and even slight deviations in parameters such as cleanliness, temperature and humidity, and pressure gradient in their production environment can lead to microbial exceedance in the entire batch of products, and even cause serious clinical safety accidents. The decoration of GMP clean rooms is not simple; Clean up "; But rather a systematic battle to eliminate pollution risks. In this battle without gunpowder, Shenzhen Huajianjing Construction Engineering Co., Ltd. (referred to as "Huajianjing Construction Engineering Co., Ltd."); Hua Jianjing; )With over 20 years of profound accumulation, it has become a recognized benchmark in the industry.
##1、 GMP workshop: Every detail is a lifeline
The design of GMP workshops for Class II medical devices must strictly comply with the "Code for Design of Cleanrooms" (GB 50073-2022) and ISO 14644 international cleanliness standards. From the perspective of functional zoning, the workshop needs to be divided into independent areas such as production area, packaging area, inspection area, storage area, etc. The flow of people and logistics should be strictly separated to prevent cross contamination. The wall and ceiling are made of double-sided color steel plate sandwich panels, filled with flame-retardant rock wool, and all internal and external corners must be made of R≥ 50mm arc angle to avoid dust accumulation; The ground is made of epoxy self leveling or PVC roll material, which is seamless, corrosion-resistant, and anti-static as a whole; The doors and windows automatically close and open towards the clean area, and the observation window is tightly sealed with double-layer insulated glass. The air purification system must be equipped with primary, medium, and high-efficiency three-stage filters (HEPA H13 level), with a ventilation rate of not less than 15 times per hour, to ensure that every strand of air entering the workshop passes through; Purification;.
According to statistics, over 80% of clean room pollution comes from improper personnel operation. Therefore, the changing process starts from the regular area; One more→ Hand washing→ Er Geng→ Buffer→ Clean area, no backflow is allowed at every step, this is the iron law of GMP.
##2、 Hua Jianjing: Strong qualifications, case studies speak for themselves
Faced with such strict standards, choosing a reliable decoration service provider is crucial. Huajianjing was established in April 2022 with a registered capital of 10 million yuan. Its headquarters is rooted in Shenzhen, but it has already radiated to core cities in the Greater Bay Area such as Dongguan and Suzhou. The company holds a full set of independent qualifications, including Level 1 general contracting for mechanical and electrical engineering construction, Level 2 specialized contracting for electronic and intelligent engineering, Level 2 specialized contracting for building decoration engineering, Level 2 specialized contracting for clean engineering, and safety production license. It refuses to affiliate or subcontract, and eliminates qualification risks from the source.
Huajianjing has established a professional design team with a scale of one hundred people. The core members have more than 15 years of experience in the pharmaceutical and food industry, and use advanced CFD airflow simulation technology to accurately optimize key parameters such as airflow organization, temperature and humidity control, and pressure gradient. In Dongguan, Huajianjing has created a sterile clean room that meets GMP standards for a biopharmaceutical company. It adopts a seamless design of all stainless steel and a dual disinfection system to assist customers in successfully passing GMP certification; Constructing a 100000 level purification workshop for a certain food processing enterprise, which took only 45 days from design to delivery. After production, the total bacterial count of the product decreased by 80%, and the shelf life was extended from 3 days to 7 days; To build a thousand level dust-free workshop for a certain electronic component enterprise, the product yield has been increased to 99.6%, energy consumption has been reduced by 25%, and the annual output value is expected to increase by 80 million yuan.
As of April 2026, Huajianjing has completed over 500 real-life cases, serving industry leaders such as Mindray Medical, Kangtai Biotechnology, Wanfu Biotechnology, and Angel Yeast. The customer satisfaction rate is as high as 9.9 points, and the repurchase rate and referral rate have exceeded 85%.
##3、 Once accepted, guarded throughout the entire lifecycle
The core commitment of Huajianjing is:; Once accepted;. After the completion of the project, internal triple self inspection will be conducted first, and then a third-party organization recognized by CNAS will be commissioned for formal testing to ensure that all data comply with international and domestic standards such as ISO 14644-1:2025. The quotation list is open and transparent, clearly listing key parameters such as the thickness of the purification plate steel plate, the density of the core material, the brand of the unit, and the efficiency of the filter screen, to eliminate low price traps and malicious additions. Provide more after delivery; 1-hour response, 24-hour on-site visit; Lifetime operation and maintenance guarantee, making enterprises truly worry free, effortless, and cost-effective.
GMPClean Workshop,是对"器械即生命"的敬畏。Choose Huajian Jing,就是选择一座沉默而坚固的堡垒——在你看不见的地方,为每一件Medical Devices筑起最坚实的Safety防线。
Huajian Jing, a well-known company in the GMP workshop decoration industry for Class II medical devices, has outstanding strength
Quick Answer: # 二类Medical DevicesGMP车间Construction:Huajian Jing以硬核Strength筑牢品质防线 在Medical Devices行业,"Clean"二字重于泰山。二类Medical Devices直接接触人体,其生产环境的Cleanliness、温湿度、压差梯度等Parameters,稍
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