As a core aseptic barrier device for material transfer in clean environments, the VHP (Vaporized Hydrogen Peroxide) Pass box directly impacts production compliance, product quality safety, and production efficiency for customers across industries such as pharmaceuticals, food, and biological research. As a relatively large-scale and technologically strong equipment supplier in the clean technology field in South China, Cigeair Group integrates design, manufacturing, sales, and installation services. Its self-developed VHP Pass boxes strictly follow the ISO9001 quality management system, ISO14644-1 standards, and national pharmaceutical GMP requirements, deeply adapting to the cleanliness needs of various industries. Leveraging core technical advantages and high cost-effectiveness, Cigeair provides reliable aseptic transfer solutions for customers across different sectors.
This guide combines the product features, core advantages, and practical application scenarios of Cigeair's self-developed VHP Pass boxes to offer customers a scientific, accurate, and actionable reference for selection. It helps customers avoid common pitfalls and choose the Cigeair self-developed VHP Pass box that best suits their needs with optimal cost-effectiveness, achieving standardized and efficient control of the sterilization transfer process. I. Core Principles for SelectionCompliance / Scenario Adaptability / After-Sales Support
Taking into account the core needs of various industries (pharmaceutical, food, biological research, etc.) and the product positioning of Cigeair's self-developed VHP Pass box, the selection of a VHP Pass box must adhere to four core principles: "compliance, scenario adaptability, cost-effectiveness, and reliable after-sales support." It should also consider compatibility with the customer's own clean system and long-term operating costs, ensuring that the selected equipment not only meets industry standards but also fully leverages the technical advantages of Cigeair's products.
Model Selection Precautions
VHP Pass Box
01
Compliance Principle
When selecting a VHP Pass box, it is essential to strictly comply with the regulatory standards of the customer's industry, including the Good Manufacturing Practice for Drugs (2020 Revision), the General Hygiene Code for Food Production, ISO 14644 Cleanroom Standards, FDA 21 CFR Part 11, and other domestic and international standards. Cigeair's self-developed products have passed rigorous compliance testing and can provide complete third-party sterilization validation reports, equipment certificates, and other compliance documents, ensuring that customers successfully pass industry audits and avoiding production interruptions or product recalls caused by non-compliant equipment.
02
Scenario Matching Principle
The selection of a VHP Pass box must take into account the temperature, cleanliness level, material type, and sterilization requirements of the core application scenario (e.g., pharmaceutical sterile workshops, food cold storage rooms, biological sample banks, etc.).
03
Cost-Effectiveness Principle
When selecting a VHP Pass box, it is necessary to balance procurement costs with long-term operating costs (reagent consumption, energy consumption, maintenance expenses). Prioritize products with "appropriate configuration, low energy consumption, and long service life" to avoid cost waste from blindly pursuing high-end configurations.
03
After-Sales Support Principle
When selecting a product, special attention should be paid to the manufacturer's after-sales service capability. As a self-developed manufacturer, Cigeair has a comprehensive after-sales system, offering on-site installation, commissioning, operational training, spare parts supply, and 24-hour emergency repair services, with a warranty period of at least one year. This ensures long-term stable operation of customer equipment and reduces downtime losses. This is one of the core advantages of choosing Cigeair's self-developed products.
II. Core Selection Parameters for VHP Pass BoxCore Sterilization Parameters
The core parameters of Cigeair's self-developed VHP Pass box directly determine its sterilization effectiveness, adaptability, and compliance. When selecting a product, customers should focus on the following parameters, matching configurations to their own needs to fully leverage the technical advantages of Cigeair's self-developed solutions and avoid a disconnect between parameters and actual requirements.
Sterilization Efficiency:Cigeair's self-developed VHP Pass boxes all achieve sterile-grade sterilization standards, with a kill rate of ≥99.9999% (log reduction value ≥6) for resistant microorganisms such as Bacillus subtilis var. niger (ATCC9372). This meets the high-standard aseptic requirements for pharmaceutical sterile preparations and biological sample transfer. Customers can select products with corresponding sterilization configurations based on their required sterility level without the need for additional upgrades or modifications.VHP Concentration Control:Equipped with Cigeair's proprietary dual-sensor dynamic concentration control system, the VHP concentration can be stably maintained between 8-12 mg/L (effective sterilization threshold), with a concentration monitoring deviation of ≤0.5 mg/L. This thoroughly solves the industry pain point of traditional single-sensor systems where "a single point meets the standard but the entire area is uneven." It supports dynamic concentration adjustment based on the microbial load of customer materials, adapting to material transfer needs at different risk levels while balancing sterilization effectiveness and material safety.Sterilization Dead Zones:Utilizes Cigeair's self-developed 360° multi-nozzle plus three-dimensional airflow circulation design, with adjustable nozzle angles (0-120°), completely eliminating sterilization dead zones such as corners of the pass box and gaps in material racks. This adapts to the transfer needs of irregularly shaped customer materials (e.g., bottled liquid drugs, bagged excipients, biological sample boxes), eliminating concerns about incomplete sterilization.Residue Control:Through Cigeair's independently optimized dual-process of ventilation displacement and catalytic decomposition, the residual hydrogen peroxide concentration after sterilization is reduced to ≤0.1 mg/m³ (far below the safety standard of ≤1 ppm). This prevents residual residue from corroding customer materials, damaging equipment, or affecting operator health. It is suitable for scenarios with high material safety requirements, such as food and pharmaceuticals, and represents one of the core competitive advantages of Cigeair's self-developed products.
Structure and Material Parameters
VHP Pass Box
01
Material Requirements
The inner walls of Cigeair's self-developed VHP Pass boxes are made of 316L stainless steel (304 stainless steel is available for some high-cost-performance series), offering strong corrosion resistance and easy cleaning. All welds are polished, with a surface roughness Ra ≤0.4 μm, eliminating dead corners and dirt accumulation, meeting GMP material requirements for clean equipment. The observation window uses sealed tempered glass, combining sealing and visibility, allowing customers to monitor material transfer and sterilization processes in real time, suitable for the cleaning control needs of clean workshops across various industries.
02
Sealing Performance
Utilizes Cigeair's self-developed food-grade silicone rubber double sealing gasket (3 mm compression) combined with a rotary compression door lock structure. The overall leakage rate is ≤0.1 Pa (far below the GMP requirement of 0.5 Pa), effectively preventing VHP leakage and external contamination ingress. It is also suitable for low-temperature scenarios, preventing low-temperature aging failure of the sealing gasket, extending product service life, and reducing customer maintenance costs.
03
Door Design
Equipped with a mechanical + electronic double interlock structure, ensuring that both doors cannot be opened simultaneously, preventing air pressure differential damage and cross-contamination in the clean zone, and ensuring a stable clean environment for customers. The doors support manual or automatic control, are easy to open and close, and are suitable for high-frequency material transfer scenarios, improving operational efficiency. Some high-end series can be upgraded to fully automatic induction doors based on customer needs, further optimizing the user experience.
04
Low-Temperature Adaptability
For low-temperature scenarios such as food freezing and biological sample banks, Cigeair has specially developed a low-temperature adaptable series of VHP Pass boxes, supporting stable operation across a full temperature range of -30°C to 50°C. Through a self-developed anti-freezing piping design, it solves industry pain points of traditional pass boxes such as failure of lamps to start, freezing of disinfectants, and ice blockage of pipelines under low temperatures, ensuring normal sterilization function in low-temperature environments. This is also a core advantage that distinguishes Cigeair's self-developed products from similar products.
Control System and Safety ParametersControl System: Equipped with a PLC control system, supporting one-key start and parameter settings (sterilization time, concentration, temperature, etc.). Simple operation requires no professional maintenance personnel, suitable for the skill level of frontline operators. It has data traceability functions, automatically storing data such as concentration, time, and pressure for each sterilization cycle, with a storage period of ≥3 years, complying with FDA 21 CFR Part 11 requirements, helping customers achieve compliant control and easily pass industry audits. Additionally, the control system supports integration with customers' existing clean zone monitoring systems and isolator systems, enabling sterilization program linkage and data synchronization, reducing additional debugging costs for customers.Safety Protection: Equipped with multiple safety protection functions such as VHP leakage alarm, over-temperature alarm, and door interlock alarm. When an abnormality occurs, the equipment will shut down and alarm promptly, avoiding potential safety hazards. During sterilization, the pass box maintains a negative pressure of -5 to -10 Pa. Even if a minor leak occurs, it prevents VHP from leaking into the clean workshop, protecting the safety of customer operators and meeting safety production requirements across industries.Size Selection:Cigeair's self-developed VHP Pass boxes are available in standard sizes and customization services. Common standard size references:500×500×500 mm (small, suitable for biological samples, small reagent transfer)800×800×800 mm (medium, suitable for pharmaceutical and food excipient transfer)1000×1000×1000 mm (large, suitable for large materials or batch transfer)Customers can contact the Cigeair sales team to customize specific dimensions based on their site space, material size, and transfer frequency, avoiding energy waste from oversized units or efficiency loss from undersized units. III. Scenario-Based Selection GuideCompliance / Scenario Adaptability / After-Sales Support
Cigeair's self-developed and manufactured VHP Pass boxes cover four series, respectively adapting to the scenario needs of customers in different industries such as pharmaceuticals, food, and biological research. Customers can select based on their own industry scenario and core requirements, achieving "on-demand selection, precise adaptation," fully leveraging product advantages while reducing procurement and operating costs.
(I) Pharmaceutical Sterile Preparation Workshop (Injectables, Biologics)Customer Scenario Characteristics:High cleanliness grade requirements (Grade A/B), requiring sterile-grade sterilization. Materials are mostly sterile utensils, liquid drugs, and finished products. Extremely high demands for sterilization effectiveness, residue control, and compliance. Some scenarios involve low-temperature storage, requiring equipment with comprehensive data traceability to meet export compliance needs.Selection Points: Product sterilization rate ≥99.9999%, equipped with Cigeair's self-developed dual-sensor dynamic concentration control system, VHP concentration adjustable (8-12 mg/L), accompanied by SGS third-party sterilization effectiveness validation reports, ensuring compliance with GMP Appendix "Sterile Drugs" requirements, helping customers pass domestic and international compliance audits. Use 316L stainless steel material, seal leakage rate ≤0.1 Pa, equipped with residue detection device ensuring residual concentration ≤0.1 mg/m³ after sterilization, preventing contamination of sterile materials and ensuring drug quality safety. The control system supports data traceability and integration with isolator systems, meeting FDA 21 CFR Part 11 requirements, adapting to customer needs for pharmaceutical export to European and American markets. For workshops involving low-temperature storage, the low-temperature adaptable version of this series can be selected, supporting stable operation from -10°C to 50°C, avoiding sterilization failure under low temperatures.(II) Food Freezing/Refrigeration Workshop (Aquatic Products, Dairy Products, Frozen Foods)Customer Scenario Characteristics:Low temperature (-30°C to 0°C). Materials are mostly frozen foods and raw materials. Requires rapid sterilization to avoid microbial contamination (e.g., Salmonella, Listeria), while also preventing low-temperature damage to equipment. Balances operational efficiency with long-term operating costs, with high demands on equipment durability.Selection Points:Cigeair's self-developed product specifically for low-temperature scenarios, supporting stable operation across a full temperature range of -30°C to 50°C. Equipped with a self-developed anti-freezing piping design, solving pain points of traditional pass boxes such as failure of lamps to start and pipeline icing under low temperatures, ensuring stable sterilization efficiency under low-temperature environments, with a kill rate ≥99.999%. Sterilization time controlled within 15-30 minutes, adapting to customers' high-frequency material transfer needs without extending production rhythm. VHP concentration adjustable, setting appropriate sterilization parameters for different food materials (e.g., frozen meat, dairy products), balancing sterilization effectiveness with food quality. Material uses corrosion-resistant, easy-to-clean 316L stainless steel, paired with Cigeair's self-developed low-temperature anti-aging sealing gasket, providing excellent sealing performance, preventing external contaminant ingress while extending equipment service life. Low energy consumption and simple maintenance, significantly reducing operating costs for customers' food production.(III) Biological Sample Bank (Stem Cells, Research Samples)Customer Scenario Characteristics:Extremely low temperature (-30°C to -10°C). Samples have high requirements for sterilization effectiveness, transfer time, and activity protection. Needs to avoid sample contamination and activity loss. Requires comprehensive data traceability to meet research compliance needs. Materials are mostly small sample boxes and reagent bottles.Selection Points: Strong low-temperature adaptability, supporting stable operation at -30°C. Equipped with Cigeair's self-developed anti-freezing piping and low-temperature insulation design, preventing equipment components from low-temperature damage, ensuring uninterrupted sterilization function during sample transfer, guaranteeing sample sterility and safety. Sterilization time controlled within 15-25 minutes, reducing sample exposure time and protecting sample activity. VHP residue ≤0.1 mg/m³, avoiding residue corrosion of sample containers or impact on sample quality, meeting the high requirements of research samples. The control system features precise parameter control and data traceability, capable of recording complete sterilization process data in real time, facilitating customer research traceability and compliance audits. Chamber dimensions suitable for small items like sample boxes and reagent bottles, equipped with layered material racks to avoid sample compression while improving transfer efficiency.(IV) Non-Sterile Pharmaceutical/Food Workshop (Oral Solid Dosage Forms, General Foods)Customer Scenario Characteristics:Moderate cleanliness grade requirements (Class 10,000/100,000). Requires surface disinfection and cleanliness maintenance. Materials are mostly raw materials, excipients, and packaging materials. Relatively mild requirements for sterilization grade, focusing on procurement cost and operational convenience, without the need for complex parameter debugging.Selection Points:Outstanding cost-performance ratio. Sterilization rate ≥99.99%, VHP concentration adjustable (7-10 mg/L), meeting customers' basic sterilization and cleanliness needs. Affordable pricing, suitable for batch procurement. Material can be 304 stainless steel (lower cost), seal leakage rate ≤0.1 Pa, equipped with basic interlock and alarm functions, meeting customers' daily clean transfer needs. Simple operation, easy maintenance, requiring no complex parameter debugging, suitable for the skill level of frontline operators in customer workshops, reducing operational costs. Supports standard sizes and simple customization, allowing flexible selection based on customer site and material dimensions, adapting to the scenario needs of non-sterile workshops, while enjoying Cigeair's comprehensive after-sales service guarantee. IV. Core Advantages of Cigeair Self-Developed VHP Pass BoxCompliance / Scenario Adaptability / After-Sales Support
As a self-developed and self-manufactured enterprise, Cigeair's self-developed VHP Pass boxes offer five core advantages compared to similar products. These are also the key considerations for customers when making a selection, helping customers achieve "peace of mind in purchase and ease of use."
Q
Self-Developed Technology Advantages
A
Cigeair has a professional R&D team focusing on customer pain points. It has independently developed core technologies such as a dual-sensor dynamic concentration control system, 360° dead-angle-free sterilization design, and low-temperature anti-freezing technology, solving industry problems of traditional pass boxes such as uneven sterilization, low-temperature failure, and excessive residue. The products feature leading technology and adapt to multiple scenario needs. At the same time, the company adheres to the values of "innovative development, pursuit of excellence" and continuously optimizes product technology.
Q
Quality Assurance Advantages
A
The production process strictly follows the ISO9001 quality management system. There are multiple professional workshops for sheet metal, baking paint, welding, and assembly. All products undergo strict factory testing and third-party validation. Material, performance, and compliance are guaranteed. The quality is stable and reliable, with a long service life, practicing the quality concept that "quality is the lifeline of the enterprise."
Q
Customization Advantages
A
Based on customers' specific scenario requirements (size, temperature, sterilization grade, control system integration, etc.), Cigeair provides exclusive customization services. From solution design, R&D and production to installation and commissioning, one-to-one service is provided throughout the process, ensuring that the product precisely adapts to customer needs. This differentiates from standard similar products, meets customers' differentiated needs, and practices the business philosophy of "quality, innovation, win-win."
Q
High Cost-Effectiveness Advantages
A
Through self-development and self-manufacturing, intermediate agent links are eliminated, achieving "direct supply from the manufacturer" and significantly reducing procurement costs. At the same time, the products feature low energy consumption and easy maintenance, reducing customers' long-term operating costs. Balancing quality and cost-effectiveness, Cigeair allows customers to obtain high-quality aseptic transfer solutions within a reasonable budget.
Q
Comprehensive After-Sales Advantages
A
Cigeair provides on-site installation, commissioning, and operation training services. Spare parts supply (such as sealing gaskets, VHP reagents, sensors, etc.) is timely. The warranty period is ≥1 year. With 24-hour emergency repair capability, Cigeair quickly responds to customer fault needs, reducing equipment downtime. In addition, long-term operation and maintenance consulting services are provided, ensuring stable equipment operation for customers in all aspects.
V. Customer Selection Process and Acceptance ChecklistAvoid Procurement Risks, Ensure Product Compliance Selection ProcessRequirement Definition: The customer clearly defines their application scenario (temperature, cleanliness level, material type, transfer frequency), sterilization requirements, compliance standards, and budget, identifying core selection needs.Product Consultation: Contact the Cigeair sales team, communicate the requirements, and let the professional sales staff recommend suitable self-developed VHP Pass box series and models based on the needs, explaining product parameters, advantages, and pricing.Solution Confirmation: Cigeair provides a detailed product solution (including dimensions, configuration, customization details, quotation, delivery lead time) according to the customer’s requirements. After confirming the solution, the customer signs the purchase contract.Production and Delivery: Cigeair self-develops and manufactures the product per the contract, conducts factory testing, and delivers it on time after passing inspection.Installation and Acceptance: Cigeair arranges professional personnel for on-site installation, commissioning, and training of the customer’s operators. The customer completes the acceptance following the acceptance checklist and confirms that the product meets the requirements. Acceptance ChecklistAppearance and Structural Acceptance: Check whether the equipment material, welds, and seals comply with the contract (e.g., 316L/304 stainless steel). Verify that the door interlock functions properly, the chamber has no dead corners and is easy to clean. For low‑scenario equipment, inspect the anti‑freezing structure for completeness. Ensure no damage or scratches on the exterior.Performance Validation: With assistance from Cigeair technical staff, test sterilization efficiency, VHP concentration distribution, residue concentration, and seal leakage rate – all must meet contractual and industry standards. For low‑temperature scenarios, conduct a full-temperature-range operation test from -30°C to 50°C to ensure stable equipment operation.Compliance Documentation Acceptance: Cigeair must provide the equipment certificate of conformity, test report, sterilization validation report, compliance certificate, and other documents to meet the regulatory requirements of the customer’s industry.Operation Training Acceptance: Cigeair technical staff must provide comprehensive training to the customer’s operation and maintenance personnel, ensuring that relevant personnel master equipment operation, parameter setting, routine maintenance, and fault handling. Acceptance is completed only after the training is qualified. VI. Daily Operation and Maintenance RecommendationsRoutine Maintenance and Troubleshooting Daily Maintenance: Clean the equipment chamber and observation window every day to remove material residues. Check the sealing gasket and nozzles weekly to ensure they are intact; replace aging sealing gaskets in time (Cigeair can provide original spare parts). Calibrate the VHP sensor and concentration controller monthly to ensure parameter accuracy. Replace the VHP reagent and HEPA filter quarterly; regularly inspect low-temperature adaptable components (e.g., anti-freezing piping) and maintain a maintenance log.Operating Precautions:Operators must strictly follow the operating procedures to start the equipment, ensuring sterilization parameters are set correctly. During material transfer, avoid blocking the VHP nozzles; irregularly shaped materials should be placed on separate layers to ensure no sterilization dead zones. In low-temperature scenarios, preheating is required before starting the equipment to avoid low-temperature damage to electronic components. After sterilization, confirm that the residue concentration meets the standard before opening the doors to prevent residue leakage.Troubleshooting: In the event of leakage alarms, sterilization failure, or other faults, immediately shut down the equipment and troubleshoot (e.g., aging sealing gasket, sensor failure, insufficient VHP reagent, etc.). If the problem cannot be resolved internally, contact the Cigeair after-sales team promptly. Do not operate the equipment improperly. When the equipment fails to start in low-temperature scenarios, check the anti-freezing components and power supply, and avoid forced startup that could damage the equipment.Compliance Control: Regularly organize equipment operation data, maintenance logs, and validation reports to ensure data traceability and meet industry compliance audit requirements. Annually, you may contact Cigeair to commission a third-party organization to conduct a comprehensive sterilization effectiveness validation to ensure the equipment continues to meet usage standards over the long term.
When selecting a VHP Pass box, the core considerations for customers are "adapting to their own scenario, ensuring compliance, balancing cost-effectiveness and after-sales service." Cigeair's self-developed and manufactured VHP Pass boxes, with their proprietary technological advantages, high-quality assurance, customization services, excellent cost-effectiveness, and comprehensive after-sales system, can precisely meet the needs of customers in pharmaceuticals, food, biological research, and other industries. They effectively solve customer pain points in aseptic transfer, helping customers achieve standardized and efficient control of clean transfer processes, ensuring product quality and safety, and reducing compliance risks and operating costs.
This guide, combining the product characteristics of Cigeair's self-developed VHP Pass boxes with practical customer needs, provides a comprehensive selection reference. Customers can choose the appropriate product series and model based on their own scenarios, requirements, and budget. For customization needs or further consultation, please feel free to contact the Cigeair sales team. We will provide one-on-one professional services to help customers select the most suitable self-developed VHP Pass box.Cigeair – Embracing first-class purification technology, creating an immaculate world, and providing high-quality clean equipment and solutions for customers across industries with independent R&D strength.
English
