Requirements and design specifications for food grade biological fermentation

I. Introduction

With the increasing attention to food safety, nutrition and sustainable production, biological fermentation technology has been widely used in food industry. Whether it is dairy products, brewed beverages, or food additives such as amino acids, enzyme preparations, probiotics and other products, their production is mostly inseparable from the tightly controlled food grade biological fermentation process. Food grade biological fermentation not only ensures product quality and purity, but also follows a series of stringent hygiene, safety and process specifications. This paper aims to systematically discuss the core requirements and key design specifications of food-grade biological fermentation, so as to guide the standardization construction and production of related enterprises.

II. Basic requirements of food-grade biological fermentation

1. Food safety

The primary goal of food-grade biological fermentation is to ensure that the product is not harmful to human health. To do this, the selected microbial strains must meet food Safety regulations, such As the European Union's QPS (Qualified Presumption of Safety) or the United States FDA's GRAS (Generally Recognized As Safe) standard. Toxicological assessment and allergen risk analysis are required for any genetically engineered strains.

2. Traceability and food-grade certification of raw and auxiliary materials

All raw materials used in the fermentation process, including media, additives, cleaning agents, etc., must have food-grade certification and be batch traceable throughout the production process. This is the premise to achieve food safety and control.

3. Hygiene control and aseptic operation

In food-grade fermentation, prevention of contamination is crucial. Equipment, pipes, valves, storage tanks, etc. must be designed aseptically; Operators should comply with the clean area management code and wear clean clothing in accordance with GMP standards. Fermenters and related facilities should have CIP (in situ cleaning) and SIP (in situ sterilization) capabilities.

4. Environmental control

Air, water, steam and other supply systems must be cleaned, especially fermentation gases (such as air, oxygen, CO₂) need to pass through a bactericidal filter. The plant should comply with the food clean plant design specifications (such as GB 50687-2011), with reasonable air flow control and pressure difference zoning to prevent cross-contamination.

MIKEBIO production type fermetation system for  lactobacillus

III. Design specifications for food-grade fermentation equipment

1. Fermenter structure and material requirements

Material: The tank should be made of 304 or 316L food grade stainless steel material, the internal surface roughness is less than 0.4μm, polished treatment, to avoid hanging material and bacteria breeding.

Sealing: All sealing interfaces, manholes and sight glasses must have excellent sealing performance to prevent gas leakage or external pollutants from entering.

Mixing system: Select the top or bottom mixing device according to the characteristics of the material, equipped with anti-shear and anti-caking design to ensure that the fermentation liquid is fully mixed.

Control system: Automatic control functions are required, including real-time monitoring and recording of temperature, pH, DO, stirring speed, feeding, exhaust and other parameters.

2. Cleaning and Sterilization system (CIP/SIP)

CIP system design: It is required to be equipped with high pressure circulating pump and spray ball to ensure that the whole tank and pipeline have no dead corner cleaning; The ratio of common cleaning agents such as NaOH and pickling solution must be accurate.

SIP system design: Generally, high-temperature saturated steam above 121°C is used for sterilization for more than 30 minutes to ensure a sterile production environment; The steam must be clean steam, and the pipe should keep the slope to discharge condensate.

3. Control and traceability system

The whole fermentation process should have SCADA or DCS system to realize automatic data collection, process alarm, batch record and other functions.

The system shall comply with FDA 21 CFR Part 11 electronic Records specification to ensure the authenticity, integrity, and traceability of data.

IV. Process flow and operation specifications

1. Process flow

Typical food-grade fermentation processes include: inoculation preparation → fermentation → cooling → separation/concentration → sterilization/drying → packaging. Each link requires strict control of parameters and operating specifications:

• Pre-inoculation inspection: to verify the activity and pollution-free status of the strain;
• Fermentation parameter setting: such as temperature control at 3037℃, pH maintained at 5.57.0, according to different strains of optimization;
• Gas control: ventilation and dissolved oxygen control affect fermentation efficiency, and the set range needs to be maintained through PID control.

2. Operator management

All personnel entering the fermentation plant must undergo GMP training;

Avoid unnecessary human intervention in operation, reduce the opening operation;

SOP (Standard Operating Procedure) should be developed to guide each step and record the whole process.

V.Quality control and testing standards

1. Microbial detection

During the fermentation process, the total number of colonies, Escherichia coli and pathogenic bacteria should be detected regularly.

The aseptic area has a monitoring system for settling bacteria and floating bacteria.

The final product is subject to microbiological limit testing and endotoxin testing.

2. Physical and chemical index detection

Including pH, concentration, viscosity, residual sugar, protein/amino acid content, etc.;

Products comply with national or international food additive standards (e.g. GB2760, FAO/WHO specifications);

HPLC, GC-MS, UV and other instruments were used to ensure the analysis accuracy.

MIKEBIO bio fermentation system for  edible  fungi production

Vi. Conclusion

The core of food grade bio-fermentation is that it is "safe, clean and controllable". In the context of increasingly strict food regulations and consumers' growing demand for healthy products, the construction of a biological fermentation platform that meets food grade standards is not only an inevitable requirement for enterprise quality management, but also an important guarantee for the sustainable development of enterprises. Through the comprehensive and standardized management of raw materials, equipment, process and personnel, the quality safety and consistency of each batch of food fermentation products can be ensured.

On the other hand, when choosing a bioreactor fermenter, it is necessary to find a regular manufacturer with good reputation and strength, so as to ensure the quality of the product. Jiangsu Mike Biotechnology Co., Ltd. was established in 2008, is a focus on biological fermentation equipment research and development, production and sales of high-tech enterprises. Our company has a pilot fermentation platform, which is integrated with intelligence and automation, and has built a mature fermentation system, which can realize the optimization of pilot fermentation process, commissioning development of all process processes from pilot fermentation production to fermentation product separation and purification, and set up a doctor workstation and a modern laboratory.

Our company has a standardized production plant, with complete sets of equipment and tools required for installation, mainly including a variety of machine tools, automatic argon arc welding machine, automatic polishing machine, automatic cutting machine and flaw detection machine and other more than 60 sets of production and testing equipment, the production process all realize modern standard operation, to provide customers with more professional quality and technical support.