TURNKEY PROJECT

Shanghai Qualia Biotechnology Co., Ltd. specializes in various turnkey projects related to pharmaceuticals, veterinary drugs, biosafety technology, and related industries, from design, supply, installation to verification services.

1. Design

In the design phase of a biosafety turnkey project, the main task is to develop a detailed design plan to ensure that the project meets biosafety, GMP specifications and customer needs. The design content typically includes:
Biosafety level planning: Determine the level requirements of the corresponding biosafety laboratory or production workshop according to the biological risk level involved in the experiment or production activities.
Process design: Combined with the characteristics of biological process, design a reasonable process flow to ensure the sterility and pollution-free operation process.
Architectural layout design: Reasonably plan the layout of the laboratory or production workshop, including the flow of people, logistics, airflow, etc., to ensure that the functions of each area are clear and do not interfere with each other.
Equipment selection and configuration: According to the process flow and biosafety requirements, select and configure appropriate experimental equipment, production equipment and auxiliary facilities.
Environmental control system design: Design an effective environmental control system, including ventilation, air conditioning, purification, etc., to ensure that the temperature, humidity, cleanliness and other environmental parameters of the laboratory or production workshop meet the requirements.

2. Project Management

Project management is the core part of a turnkey biosafety project, and the main tasks include:
Project plan formulation: Formulate a detailed project plan, including schedule arrangement, resource allocation, quality control, etc., to ensure that the project is carried out as planned.
Construction team organization: set up a professional construction team, including professionals in design, construction, installation, commissioning and other links.
Construction supervision and coordination: During the construction process, the project progress, quality, safety, etc. are comprehensively supervised and coordinated to ensure the smooth progress of construction activities.
Risk management: Identify the risks that the project may face, formulate risk response measures, and reduce the impact of risks on the project.

3. GMP Services

GMP Training: Provide GMP training to project stakeholders to ensure they understand and comply with GMP specifications.
GMP audit and certification: Assist customers in GMP audit and certification to ensure that the laboratory or production workshop meets GMP requirements.
GMP Consulting: Provide customers with GMP consulting services to answer their questions and confusion in the process of GMP implementation.

4. Critical Installation

The critical installation phase is critical to the implementation of a biosafety turnkey project, and the main tasks include:
Equipment installation and commissioning: In accordance with the design scheme and GMP requirements, the experimental equipment, production equipment and auxiliary facilities are installed and debugged to ensure the normal operation of the equipment.
Installation and commissioning of environmental control system: Installation and commissioning of environmental control system to ensure that the environmental parameters of the laboratory or production workshop meet the requirements.
Pipeline and line installation: Installation of pipes and lines required in the experimental or production process, such as water supply and drainage pipelines, gas pipelines, electrical lines, etc.
Validation & Testing: Validate and test installed equipment to ensure that equipment performance meets design requirements and can meet biosafety and GMP requirements.

Clean Room System

Cleanroom systems play a vital role in modern industrial, medical, scientific and other fields, and their design, construction and operation need to be comprehensively considered to ensure that specific cleanliness requirements are met and that a safe and efficient working environment is provided.

Architecture
Cleanroom building materials need to be corrosion-resistant, easy to clean, low volatility and dust-free. Commonly used building materials include stainless steel, glass, special coatings, and flooring materials. Stainless steel is often used on cleanroom walls, ceilings and floors due to its excellent corrosion resistance and ease of cleaning; Glass, on the other hand, is often used in observation windows and partitions because of its high transparency and easy cleaning. Special coatings and flooring materials can effectively reduce the adhesion of dust and microorganisms, and improve cleanliness.

Structure & Layout
The structural design of the cleanroom needs to consider the uniformity and stability of the airflow to reduce the accumulation of particulates and harmful substances. The surrounding structure is often made of color steel plates, aluminum profiles and other materials, combined with a well-sealed door and window system to ensure effective isolation between indoor and outdoor. At the same time, the layout of the equipment in the clean room needs to meet the process requirements, and take into account the impact of the equipment on air quality, so that the equipment is easy to clean and maintain, and can operate in harmony with other equipment.

Air filtration system
At the heart of a cleanroom is the air filtration system, which effectively removes particulates and harmful substances from the air. Depending on the cleanliness requirements, it is necessary to select the appropriate filter type and size, such as medium efficiency filter and high efficiency filter. The medium efficiency filter is usually installed in the positive pressure section of the clean air handling unit, while the high efficiency filter is installed at the end of the clean air conditioning system to ensure that the air is adequately filtered as it passes through the system.
Temperature and humidity control
The temperature and humidity in the cleanroom have a significant impact on the working environment and product quality. Therefore, it is necessary to design a reasonable temperature and humidity control system to control the indoor temperature and humidity within a suitable range through air conditioning equipment, humidifiers and dehumidifiers to meet specific process and product requirements.

Ventilation system design
The ventilation system should be able to provide enough fresh air and maintain the appropriate air flow rate and direction to ensure that particulates can be effectively removed. Ventilation systems also need to consider factors such as air circulation, filter replacement, and exhaust air to ensure the stability and efficiency of the system. In pharmaceutical cleanrooms, special attention should also be paid to preventing cross-contamination of hazardous substances and ensuring that air is not recycled in areas where hazardous substances may be generated.

Associated Equipment
Purification equipment
There are many kinds of purification equipment required for clean rooms, including air showers, transfer windows, laminar flow hoods, FFU laminar flow air supply units, high-efficiency air supply outlets, etc. As a necessary passage for people or goods to enter the clean room, the air shower room can effectively reduce the pollution caused by entering and exiting; The laminar flow hood and FFU ensure high cleanliness in the working area through efficient filtration and uniform air supply; Clean benches and cleanrooms provide localized, high-cleanliness environments to meet specific process needs.
Ancillary Equipment
In addition to the purification equipment, the clean room also needs to be equipped with a series of auxiliary equipment, such as air conditioning host, return air duct, water tower gate valve, water pump, etc., to ensure the normal operation of the air handling system. At the same time, it is also necessary to consider the design of the electrical part, including the lighting circuit, air conditioning circuit and purification equipment circuit, etc., to ensure the safety and stability of the system.

Cleanliness monitoring system
Cleanliness monitoring systems are key to ensuring that cleanroom environments continue to meet standards. The system typically includes modules such as air quality sensors, data processing units, display and alarm systems, and central control systems. Air quality sensors are used to monitor dust particles, microorganisms and other pollutants in the air in real time; The data processing unit collects and analyzes sensor data, and immediately sends out an alarm when a pollutant concentration exceeds the standard; The display and alarm system displays air quality data in real time and automatically triggers an alarm when the standard is exceeded. The central control system integrates the cleanliness monitoring system of all operating rooms for remote monitoring and data analysis.
Automated control
In some advanced cleanliness monitoring systems, automatic control technology is also introduced. When the air quality drops, the system can automatically adjust the air conditioning and filtration equipment to quickly return to a clean state. This automatic control not only improves the response speed of the system, but also reduces the burden of manual operation and improves work efficiency.