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Biopharmaceutical Solutions

Amidst the thriving biopharmaceutical sector, demands for production environment cleanliness and safety grow increasingly stringent. TKSAGE Group leverages deep technical expertise and industry experience to deliver a comprehensive Biopharmaceutical Solution, providing full-spectrum, high-quality products and services.

Ⅰ. Core Product Introduction

Laminar Flow Pass Box

As a critical auxiliary device for cleanrooms, the Laminar Flow Pass Box is primarily used for transferring small items between clean and non-clean zones, or between cleanrooms of different classes. It significantly reduces the frequency of cleanroom door openings, lowering contamination risks. The device features a laminar airflow design with a top-down air pattern. The bottom is constructed from perforated 304 cold-rolled stainless steel plate with reinforcement ribs, ensuring efficient filtration and stable airflow. Internal cleanliness reaches Class A, effectively preventing cross-contamination. Equipped with UV lamps, it sterilizes transferred items via ultraviolet irradiation, guaranteeing the cleanliness of items entering the clean zone.

Class A Laminar Flow Hood

This air purification unit provides a localized Class 100 clean environment, effectively isolating operators from products to eliminate cross-contamination. Typically installed above critical process points, it can function as a single independent module or be combined into modular continuous clean zones. A top-mounted fan draws air from the cleanroom, which passes through a HEPA filter. Filtered clean air then vertically traverses the operational area, delivering ISO 5 (Class 100) unidirectional airflow to the core zone. It offers touch controls for fan speed adjustment, real-time airflow velocity display, differential pressure alarms, fault alarms, and automatic wind speed adjustment, meeting stringent environmental requirements for pharmaceutical processes.

Negative Pressure Weighing Room

A local purification device specifically designed for pharmaceutical, microbiological research, and scientific laboratory settings. It delivers vertical unidirectional airflow, with partial clean air recirculating within the work area and partial exhaust to adjacent zones. This maintains negative pressure in the work area, preventing cross-contamination. It effectively contains dust and particles within the work zone, preventing diffusion outside the operational area, safeguarding operators from inhaling handled substances, and ensuring a high-cleanliness environment. The operational area is protected by Class 100 vertical laminar ISO 5 airflow (NF, EN, ISO14644-1), strictly designed to comply with FDA, EU GMP, and China GMP requirements.

HEPA Air Outlet

TKSAGE's HEPA Air Outlet employs advanced liquid-trough sealing technology to ensure efficient air filtration and leak-free delivery. The device supplies clean air, filtered through a HEPA filter, into the cleanroom at a uniform and stable wind speed. This provides reliable clean air assurance for the entire production environment. Featuring a rational structural design and easy installation, it supports customized configurations based on different cleanroom layouts and needs. It effectively enhances cleanroom air quality, meeting the strict air standards of biopharmaceutical applications.

Laminar Flow Transfer Cart

Offering flexible mobility, this cart moves freely within purification workshops for item transport. Its laminar flow design maintains a clean environment around items during transit, preventing secondary contamination. Available in diverse specifications with both power cord and battery-powered options, it adapts to various operational scenarios. This provides reliable clean protection for material transportation in biopharmaceutical production processes.

Biosafety Cabinet

A vital device ensuring the safety of laboratory personnel, samples, and the environment. TKSAGE's Biosafety Cabinet utilizes advanced airflow control technology and a high-efficiency filtration system to effectively capture and filter contaminants such as microorganisms and aerosols within the work area. This provides a secure localized environment for experimental operations. Compliant with relevant international and domestic safety standards, the device incorporates comprehensive safety features including leakage protection, UV lamp sterilization, and airflow monitoring/alarms. It is widely used in biopharmaceutical microbiological testing, cell culture, and drug R&D.

Inflatable Sealing Door

As a crucial component of cleanroom enclosures, the Inflatable Sealing Door delivers exceptional sealing performance. When closed, an inflatable seal expands to achieve tight contact with the door frame, effectively preventing air leakage. This ensures stable cleanroom pressure and protects cleanliness from external interference. Constructed from high-strength materials, the door offers excellent fire resistance and sound insulation. Its automated control facilitates efficient access, enhancing workflow productivity while providing reliable protection for the overall clean environment in biopharmaceutical workshops.

Ⅱ. Implementation Scenarios

Pharmaceutical Production Workshop

Throughout all stages of pharmaceutical production—from raw material weighing and compounding to critical processes like filling and packaging—TKSAGE's products play vital roles. The Laminar Flow Pass Box ensures contamination-free material transfer into production areas. The Class A Laminar Flow Hood, installed above filling/packaging equipment, provides localized ISO 5 cleanliness to guarantee drug quality. The Negative Pressure Weighing Station prevents dust dispersion during raw material weighing, protecting operators and the environment. The HEPA Air Outlet delivers stable clean airflow across the workshop, maintaining cleanliness standards.

Microbiological Research Laboratory

Microbiological studies demand extreme cleanliness and biosafety. Biosafety Cabinets provide secure workspaces for handling microbial samples, preventing cross-contamination and operator exposure. Laminar Flow Hoods shield critical equipment, ensuring high-cleanliness conditions for experiments. Laminar Flow Pass Boxes transfer lab items without cross-contamination. Negative Pressure Weighing Room contains aerosol diffusion during microbial reagent weighing.

Vaccine R&D and Production

Vaccine development and production require exceptionally stringent environments. TKSAGE's Inflatable Sealing Doors maintain airtight integrity and stable pressure in production facilities. HEPA Air Outlets and Laminar Flow Hoods collaboratively supply ISO-compliant air throughout vaccine manufacturing. Biosafety Cabinets safeguard samples and personnel during R&D. Laminar Flow Transfer Carts preserve sterility when transporting vaccine intermediates and critical materials.

Ⅲ. Client Acclaim

Numerous biopharmaceutical enterprises and research institutions partnering with TKSAGE highly commend our solutions. A renowned biopharma company stated: "TKSAGE's Biopharmaceutical Solution provides robust support for our production and R&D. Both equipment stability and performance exceed expectations. Particularly, their after-sales team responds promptly with professional service, eliminating all operational concerns." A microbiology-focused research institution reported: "TKSAGE's products substantially enhanced our lab's safety and cleanliness. After implementing their Biosafety Cabinets and Laminar Flow Hoods, experimental accuracy and reliability significantly improved, accelerating our research projects."

Ⅳ. Industry Trends & Development Direction

The biopharmaceutical industry is rapidly evolving. Emerging technologies like gene and cell therapies demand higher cleanliness, safety, and intelligence in production environments. Industry focus increasingly prioritizes equipment efficiency, energy savings, and eco-friendliness. Concurrently, automation and digitalization drive the trend toward intelligent biopharmaceutical process control. TKSAGE Group advances with the industry, intensifying R&D to develop more efficient, intelligent, and eco-friendly cleanroom and biosafety equipment, meeting future industry needs.

Ⅴ. TKSAGE Group Advantages

Powerful R&D Capabilities: TKSAGE maintains a specialized R&D team, with technical staff constituting 36% of total employees. Team members possess extensive industry expertise, deeply understand client needs, and continuously launch innovative products and solutions. The company operates a dedicated 2,000m² R&D center with advanced facilities.

Advanced Manufacturing Capacity: The Group operates two large production bases (26,000m² and 35,000m²). Workshops feature CNC equipment, laser cutting, and automated welding systems under modern management, ensuring stable quality and high efficiency. Production strictly complies with U.S. Federal FS209E, ISO14644-1, and national GMP/U.S. FDA standards.

Comprehensive Service System: TKSAGE offers one-stop services from design consultation to installation, commissioning, and maintenance. A professional after-sales team delivers rapid response and expert technical support. Equipment operation training ensures proper usage and maintenance, extending product lifespans.

Extensive Industry Experience: Years of development have established TKSAGE's expertise across biopharma, life sciences, and healthcare. We've successfully served renowned enterprises and research institutions, mastering diverse industry needs to provide personalized, customized solutions.

Choosing TKSAGE Group's Biopharmaceutical Solution means selecting a professional, reliable, and efficient partner. We empower your biopharmaceutical success with advanced technology, premium products, and holistic services, jointly advancing industry progress.
 Tel: +86-755-89526537
+86-755-89526536
+86-755-89526639
 Fax: +86-755-89526539
 Email: zksjjh@zksjjh.com
 Add: Room 1819, Building 5A, Fenglong Shengang, No. 333 Longfei Avenue, Longcheng Street, Longgang District, Shenzhen, Guangdong

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