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  • 1. PurposeEstablish a clean room cleaning and disinfection procedure to prevent samples from being contaminated by microorganisms in the environment and affecting the accuracy of the test results.Document numberSOP ZL0014File NameQC Clean Room Cleaning and Disinfection ProceduresPreparerReviewerApproverDate of preparationYear Month DayReview DateApproval date: Year Month DayDate of publicationYear Month DayEffective DateYear Month DayIssuing departmentQuality DepartmentDistribution DepartmentQC Room2. ScopeThis standard applies to the cleaning and disinfection of QC clean rooms.3. Responsibili...

    Visits:906  |   2026-07-01

  • Medical device manufacturers must control and monitor the clean room (area) environment. Appendix C of YY 0033-2000 "Sterile Medical Device Production Management Specifications" stipulates the environmental requirements and monitoring items for sterile medical device clean rooms (areas). The standards for temperature, relative humidity, wind speed, ventilation times, and static pressure difference are based on JG]71-90 "Clean Room Construction and Acceptance Specifications"; the standard for dust count is based on GB/T16292-1996 "Test Method for Floating Particles in Clean Rooms (Areas) of Pha...

    Visits:933  |   2026-07-04

  • 1. PurposeEstablish Clean area environmental monitoring management procedures, standardize clean workshop management, and ensure that the production environment of the clean area meets the production process requirements.(Figure 1: Cleanroom Environmental Management)2. Scope of applicationThis procedure applies to the environmental management of clean areas.3. ResponsibilitiesThe head of the quality department, the head of the production department, and each inspector shall manage the clean area in accordance with this procedure.4. Cleanroom environmental management requirements4.1. Basic requ...

    Visits:1175  |   2026-07-04

  • 1. PurposeEstablish regulations for personnel control and management in clean areas of pharmaceutical factories, strengthen and standardize the hygiene requirements of clean area staff, prevent irregular behaviors from causing pollution to products and the environment, ensure that products are produced in clean areas with corresponding cleanliness, and ensure product quality.2. ScopeApplicable to all staff entering the clean area. 3. Basis for formulation"Pharmaceutical Production Quality Management Standards (Revised in 2010)" and related documents.4. Specific requirements1.Individu...

    Visits:1169  |   2026-07-04

  • 1. PurposeEstablish a management procedure for monitoring, use and maintenance of clean rooms to ensure that the environment of clean rooms meets production requirements.2. Scope100,000-level clean area in the workshop.3. ResponsibilitiesDirector of the production and manufacturing department, director of the equipment and power department, and QC personnel.4. Contents4.1 Use of clean rooms4.1.1 Before the newly built or renovated clean room is put into operation, the company's production and manufacturing department, equipment and power department, quality department and construction unit...

    Visits:931  |   2026-07-04

  • (Figure 1: Semiconductor clean room)Step 1: Understand the clean room environment. Semiconductor clean rooms require specific conditions to minimize contamination. Ensure you are familiar with the cleanliness standards and airflow requirements for the facility.Step 2: Wear the appropriate personal protective equipment (PPE). This includes cleanroom gowns, gloves, masks, and shoe covers. Use Deign brand PPE for reliable protection against contaminants.Step 3: Maintain strict hygiene protocols. Before entering the clean room, wash hands thoroughly and use hand sanitizers. Avoid bringing any unne...

    Visits:1041  |   2026-07-04

  • In the era of advanced manufacturing and cleanroom environments, integrating a touch screen dust-free workshop management system is vital. Such systems streamline operations while adhering to stringent cleanliness standards. This article explores the functionalities, benefits, and standards associated with the implementation of touch screen management systems in dust-free workshops.What is a Touch Screen Dust-Free Workshop Management System?A touch screen dust-free workshop management system is an advanced technological solution designed to monitor and manage operations in cleanroom environmen...

    Visits:1052  |   2026-06-19

  • Clean room management regulations 11. Scope of applicationAll personnel entering the clean room (including our company's personnel, manufacturers and visiting guests, etc.) are subject to these management rules.2. PurposeTo ensure the environmental quality of the clean room and reduce the company's management costs, ensure product quality and improve operational efficiency.3. Content1. Management of entering the clean room1.1 Before entering the clean room, our company's personnel must place outdoor shoes in the shoe cabinet in the shoe changing area. Employees' personal belong...

    Visits:790  |   2026-07-04

  • 1. Management of clean equipment1.1 ICU central control panelThere is a membrane switch on the central control panel in the ICU ward hall, and a purification fan switch on the panel. When the green indicator light is on, it indicates that the purification air conditioning system is operating normally; when the alarm indicator light is on, it means that the purification air conditioning system is faulty.The clean ICU purification air conditioning is a large energy consumer. In order to save energy, the clean ICU has different purification levels of working states, which can be reasonably select...

    Visits:1018  |   2026-07-04

  • Cleanrooms are specialized environments designed to control contamination. Effective operation and management of cleanrooms are critical for various industries, including pharmaceuticals, biotechnology, and semiconductor manufacturing. This article outlines the key aspects of cleanroom operation and management, focusing on best practices, compliance with international standards, and the role of Deign in ensuring optimal cleanroom performance.Understanding Cleanroom ClassificationCleanrooms are classified based on the cleanliness level, which is determined by the number and size of particles al...

    Visits:900  |   2026-07-04

  • 1. Purpose Establish a management procedure for monitoring, use and maintenance of dust-free workshops to ensure that the environment of dust-free workshops meets production requirements. 2. Scope 100,000-level clean area of the workshop. 3. Responsibilities Director of the production and manufacturing department, director of the equipment and power department, and QC personnel. 4. Contents 1...

    Visits:977  |   2026-07-04

  • Animal Facilities - Biosafety Level 3Animal facilities at Biosafety Level 3 are for animals specifically inoculated with Hazard Level 3 microorganisms, or as determined by the results of a hazard assessment. All systems, operations and procedures require annual re-inspection and certification. The following safety precautions are required:1. All requirements for Biosafety Level 1 and 2 animal facilities must be met.2. Access must be strictly controlled.3. The facility must be separated from the rest of the laboratory and the animal room by a buffer zone consisting of a double door entrance.4. ...

    Visits:663  |   2026-06-19

  • The significance of maintenance managementImportance of Maintenance ManagementThe construction of dust-free workshops requires high-quality maintenance management. This aspect is crucial for overall effectiveness.(Figure 1: Printing factory)Design vs. MaintenanceDesign and construction account for 50% of a workshop's success, while maintenance management holds equal importance.Safety in Dust-Free WorkshopsSafety management in dust-free workshops is paramount. Their construction demands high standards and airtightness.High Costs and RisksDue to high construction costs, any accidents in dust...

    Visits:753  |   2026-07-04

  • This management system establishes standardized protocols for clean room purification air conditioning, air compressor, and purified water systems. Dedicated personnel manage these critical systems to ensure optimal performance and compliance.ScopeApplies to all purification air conditioning, air compressor, and purified water systems within clean room facilities.ObjectiveEnsure system reliability, maintain environmental controls, and prevent contamination risks.Critical SystemsPurification air conditioningAir compressionWater purification1Purified Water System Requirements1Follow "Clothi...

    Visits:736  |   2026-08-28

  • High-Tech CleanroomsHigh-tech cleanrooms are the backbone of semiconductor manufacturing, where precision and cleanliness are critical. These spaces are meticulously designed to meet international standard ISO 14644, ensuring minimal particulate contamination.Deiiang™, a leader in cleanroom technology, offers innovative solutions that integrate advanced engineering principles, crafted under the guidance of industry experts like Deiiang Jason.peng and product tester Deiiang joebo.Wang.These cleanrooms leverage cutting-edge technology, utilizing HEPA and ULPA filters to remove particulate matter...

    Visits:590  |   2026-06-19

  • 1.0 PurposeIn order to enforce strict workshop work discipline, improve product quality, create a civilized and harmonious working environment and facilitate daily management.2.0 Scope of applicationApplicable to all staff who enter the mobile phone manufacturing plant without sitting in the workshop.(Figure 1: Mobile phone manufacturing plant)3.0 Workshop discipline3.1 Before entering the dust-free workshop: anti-static clothing, anti-static hats, anti-static slippers and other dust-free workshop special anti-static equipment must be worn neatly, and violators will be fined 10 yuan.3.2 It is ...

    Visits:980  |   2026-07-04

  • Class 1000 Clean Room Management SystemStandardizing Clean Room Management Methods to Ensure Optimal Cleanliness and CompliancePurposeSpecial regulations are set to standardize the clean room management method and ensure the cleanliness of the clean room.ScopeAll personnel whose work content is related to the clean room must comply with this.Project Spotlight | Class 1,000 CleanroomClean room environment designed for precision manufacturingResponsibilitiesProduction SectionOversees daily operations and compliance within the clean room environmentFactory Affairs DepartmentManages maintenance, c...

    Visits:593  |   2026-06-19

  • Introduction This management system establishes protocols for clean room operations in radiopharmaceutical production plants. Strict adherence ensures product sterility, personnel safety, and regulatory compliance. Scope Applies to all personnel, equipment, and procedures within rad...

    Visits:676  |   2026-07-04

  • The cell room is generally a special laboratory responsible for the inspection of monoclonal antibodies, HIV, somatic cells and other therapeutic preparations and diagnostic reagents, production cells and bovine serum; and includes the technical review, review, revision or drafting of the national drug standards, Class I new drugs and imported drug standards of the corresponding varieties; responsible for the development, calibration and distribution of the national standard substances of the corresponding varieties; and conducting research on corresponding technical methods and technical pers...

    Visits:994  |   2026-07-04

  • Cleanroom Cleaning Management SystemCleanroom Cleaning App and Software - Powered by Facility AppsFigure 1: Cleanroom cleaning management system1. PurposeBy establishing a Clean Room cleaning and disinfection management system, ensure that the production environment in the clean area meets GMP requirements, prevent errors and contamination, and thus ensure product quality.2. ScopeApplicable to the company's 100,000-level and above Clean area environmental cleaning and disinfection operations.3. ResponsibilitiesRoleResponsibilitiesTechnical Quality DepartmentResponsible for the environmenta...

    Visits:1110  |   2026-06-19

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