GB 31612-2023National food safety standard - Hygienic practice for bacterial preparations for food processing (English PDF)

Foreword

This document was issued on 6 September 2023 by the State Administration for Market Regulation; Standardization Administration of the PRC and takes effect on 6 September 2024.

It is a GB standard without the /T suffix: compliance is mandatory in China.

1 Scope

GB 31612-2023 covers hygienic practice in the production of bacterial preparations for food processing — the strain preparations and starter cultures that go into food as living organisms. It runs from site selection and the factory environment through factory buildings and workshops, facilities and equipment, health management, raw materials, food additives and food-related products, food safety control during production, inspection, storage and transport of products, product recall management, training, the management system and its personnel, to records and document management; Appendix A deals with microbiological control of processing. Much of it builds on the general hygienic practice standard GB 14881 and on GB 31639, adding what is particular to growing microorganisms on purpose: terms such as the original seed lot, and siting rules that keep such a plant away from the production sites of biological products. The hazard here is the reverse of the usual one. The product is a culture, so the plant cannot sterilise its way to safety; it has to keep one organism alive and every other one out, from the seed lot onward through every transfer. A mandatory national food safety standard for culture producers, the food manufacturers who buy from them, and inspectors.

This standard specifies the basic requirements and management guidelines for sites,

facilities, and personnel in the production process of strain preparations for food

processing, such as raw material procurement, strain use and management, processing,

packaging, storage, and transportation.

This standard is applicable to the production of strain preparations for food processing,

and is not applicable to products for direct consumption and distiller's yeast, red yeast

rice, etc. produced by solid-state fermentation technology.

2 Terms and definitions

The terms and definitions defined in GB 14881 and GB 31639 and the following apply

to this standard.

2.1 Original seed lot

Viable bacteria for preparing the main seed lot.

2.2 Main seed lot

A sufficient number of uniform composed viable bacteria formed after passage and

propagation of the original seed lot, which are used for preparing the working seed lot.

2.3 Working seed lot

Viable bacteria obtained from the activation and passage of the main seed lot on a

suitable culture medium, which are used for production.

3 Site selection and factory environment

3.1 Site selection

3.1.1 It shall comply with the relevant provisions of GB 14881.

3.1.2 No factory shall be built near the production sites of biological products,

chemicals, and other products that are produced by using microorganisms.

3.2 Factory environment

It shall comply with the relevant provisions of GB 14881.

4 Factory buildings and workshops

4.1 Design and layout

4.1.1 It shall comply with the relevant provisions of GB 14881.

4.1.2 The factory buildings, equipment layout, and process flow shall be reasonably

connected, the building structure shall be complete, and it shall be able to meet the

requirements of production process and hygiene. The following shall be considered in

the design.

a) Avoid cross-contamination between raw materials, semi-finished products and

finished products;

b) Requirements for temperature, humidity, and other process parameters of the

production process to prevent interference in adjacent workshops;

c) Facilitate the cleaning of the inside and outside of raw material storage tanks,

fermentation tanks, semi-finished product storage tanks, etc.;

d) The air inlet for fermentation, drying, and other processes shall be set in a dry

and clean location, and it shall be easy to clean and replace filter facilities;

e) Prevent strains, contact surfaces, or packaging materials from being

contaminated by microorganisms, chemicals, etc. through reasonable layout,

separation, and other measures.

4.1.3 The production area for bacterial strain preparations shall meet the following

requirements.

4.1.3.1 The operation area shall be divided into general work area, quasi-cleaning work

area, and cleaning work area according to the production process and hygiene

requirements.

4.1.3.2 Effective separation shall be set up between work areas with different

cleanliness classes. An independent air purification system with a filter device shall be

installed in the cleaning work area and positive pressure shall be maintained to prevent

air from non-cleaning work areas from entering the cleaning work area and causing

cross-contamination.

4.1.3.3 The enrichment, emulsification, drying, mixing, and inner packaging of

bacterial cells shall be a cleaning work area (except when the enrichment and

They shall comply with the relevant provisions of GB 14881.

5.1.3 Cleaning and disinfection facilities

They shall comply with the relevant provisions of GB 14881.

5.1.4 Waste storage facilities

They shall comply with the relevant provisions of GB 14881.

5.1.5 Personal hygiene facilities

5.1.5.1 They shall comply with the relevant provisions of GB 14881.

5.1.5.2 Disinfection facilities shall be set up at the entrance to the cleaning work area,

and secondary changing rooms and special work clothes, gloves, etc. for the cleaning

work area shall be equipped as needed.

5.1.6 Ventilation facilities

5.1.6.1 They shall comply with the relevant provisions of GB 14881.

5.1.6.2 Air filtering and regulating facilities shall be installed in the cleaning work area,

and the air filtering device shall be cleaned and replaced regularly. The air in the factory

building shall flow from the cleaning work area with high cleanliness requirements to

the quasi-cleaning work area and general work area with low cleanliness requirements.

Ventilation facilities shall be installed in general work areas to remove moist and dirty

air in a timely manner.

5.1.6.3 The air inlet shall be more than 2 m away from the ground or roof, away from

pollution sources and exhaust outlets, and air filtering equipment shall be installed

according to the requirements of the cleanliness class. The exhaust outlet shall be

equipped with an easy-to-clean, corrosion-resistant mesh cover to prevent animal

intrusion; the ventilation device shall be easy to disassemble, clean, repair, or replace.

5.1.6.4 In areas where odors, toxic and harmful gases, or dust is generated, there shall

be elimination, collection, or control devices.

5.1.7 Lighting facilities

They shall comply with the relevant provisions of GB 14881.

5.1.8 Warehousing facilities

They shall comply with the relevant provisions of GB 14881.

5.1.9 Temperature control facilities

They shall comply with the relevant provisions of GB 14881.

5.2 Equipment

5.2.1 Production equipment

5.2.1.1 General requirements

They shall comply with the relevant provisions of GB 14881.Inoculation equipment,

fermentation equipment, and enrichment equipment shall be equipped, and according

to the characteristics of the product production process, drying equipment shall be

equipped when necessary.

5.2.1.2 Materials

5.2.1.2.1 They shall comply with the relevant provisions of GB 14881.

5.2.1.2.2 Equipment and utensils in contact with semi-finished products and finished

products shall be made of materials with smooth and clean surfaces that comply with

national regulations.

5.2.1.3 Design

It shall comply with the relevant provisions of GB 14881.

5.2.1.4 Inoculation equipment

Equipment related to strain inoculation such as ultra-clean workbench shall be equipped.

5.2.1.5 Fermentation equipment

5.2.1.5.1 Fermentation tanks, etc. that are suitable for the production scale shall be

equipped, and batching tanks, seed tanks, auxiliary tanks, etc. can be equipped as

needed. If necessary, equipment such as culture medium transportation, stirring, alkali

liquid transportation, compressed air (or inert gas, carbon dioxide, etc.) transportation,

automatic heating, dissolved oxygen control, steam sterilization, cleaning and

disinfection, as well as instruments and apparatus, computer control systems, control

cabinets, etc. can be equipped.

5.2.1.5.2 Compressed air or other gases used for fermentation production shall be

filtered and purified to prevent indirect pollution.

5.2.1.6 Enrichment equipment

Enrichment equipment such as centrifuges or vacuum drum separators shall be

equipped and facilitate cleaning and disinfection.

characteristics. The environment and equipment surfaces can be cleaned and disinfected

by using hydrogen peroxide, ozone, UV, etc.; the surfaces in contact with strain can be

cleaned and disinfected by using alkali, acid, steam, etc.

6.3.4 Equipment and utensils used for cleaning and disinfection shall be placed in a

dedicated place and properly kept.

6.3.5 All production workshops shall develop a periodic schedule of cleaning and

disinfection to ensure that the surfaces of all machines, pipes, and equipment in direct

contact with strain are cleaned until the surfaces are smooth and free of bacterial

residues.

6.3.6 The cleaning and disinfection process shall be recorded, such as the type, action

time, concentration, and objects of detergents and disinfectants.

6.3.7 An effective monitoring process shall be developed to verify the effectiveness of

cleaning and disinfection to ensure that disinfection operations meet relevant

requirements.

6.4 Prevention and control of phage contamination

6.4.1 Measures to prevent and control phage contamination shall be established during

the production process of bacterial strain preparations.

6.4.2 One or more of the following methods can be used to prevent and control phage

contamination.

a) In the strain screening process, select strains that are resistant to phages, and

regularly test strain resistance;

b) During the strain preservation process, the preserved strains are regularly

separated and purified;

c) During the production process, different strains are regularly rotated;

d) During the cleaning and disinfection process, regularly conduct phage testing

on facilities and equipment in the cleaning work area;

e) In the waste treatment process, strictly control the discharge of viable bacteria.

6.5 Personnel health management and hygiene requirements

They shall comply with the relevant provisions of GB 14881.

6.6 Pest control

It shall comply with the relevant provisions of GB 14881.

6.7 Waste disposal

6.7.1 It shall comply with the relevant provisions of GB 14881.

6.7.2 Waste culture medium and bacterial cells shall be treated harmlessly.

6.7.3 Containers containing waste shall be specially marked and shall be reasonably

constructed and impermeable. The containers can be closed when necessary to prevent

product contamination.

6.8 Work clothes management

It shall comply with the relevant provisions of GB 14881.