The ISO 5 level rapid rolling-type air shower room is applicable in the scenarios of the biopharmaceutical industry.
The ISO 5 level corresponds to the US Federal 209E 100 level, which is the mandatory clean level for the core production process of biopharmaceuticals. It requires strict compliance with GMP regulations to control particle and microbial contamination. The rapid rolling-type air shower room, with its large opening, high opening and closing speed, and the ability to accommodate pallets / large-sized goods, as well as strong sealing partitions, has solved the problem of efficient and clean transportation of large quantities and large-sized materials in the biopharmaceutical industry. Its applicable scenarios cover the entire logistics chain of biopharmaceutical production, research and development, storage, and waste disposal, as follows:
1. Core sterile workshop raw materials and packaging material input scenario
This is the most core application scenario of this type of air shower room, responsible for purifying the production front-end materials and sending them into the ISO 5 level sterile core area, eliminating pollution at the source.
Sterile raw materials batch transportation
Applicable to injection raw materials, sterile auxiliary materials (such as mannitol, glucose, medicinal ethanol), biopharmaceutical culture media, adjuvants, plasmids, etc., in the form of pallets, ton bags, and sterile sealed material boxes, after surface dust removal and air purification by the air shower room, enter the sterile preparation room and raw material purification workshop. The rapid rolling door can adapt to heavy loads and large-sized material pallets, without the need to split the materials, avoiding secondary pollution caused by manual operations.
Sterile inner packaging material clean access
Used for sterile vials, ampoules, pre-sealed syringes, rubber stoppers, aluminum caps, sterile composite membranes for medicine, blood bags, etc., the entire frame and entire pallet of packaging materials pass through the air shower room for purification and then enter the washing, drying, filling and sealing linkage line and sterile filling area. The fast opening and closing of the rolling door can significantly reduce the air exchange time between the clean area and the outside, reducing the risk of micro-particles and microorganisms invading the ISO 5 level area.
2. Equipment and tool entry and maintenance scenarios
Large-scale sterile equipment and reusable tools in biopharmaceuticals need to achieve controllable circulation between the clean area and the outside to ensure the cleanliness and compliance of the equipment and tools.
Large-scale sterile equipment installation and maintenance
Sterile filling machines, freeze-drying machines, liquid mixing systems, sterilization filtration units, laminar hoods, disposable bioreactors, etc., large-scale production equipment and components, after new equipment entry, relocation, and maintenance cleaning, are surface purified by the air shower room and enter the ISO 5 level core area. The large opening size of the rapid rolling air shower room solves the pain point of traditional flat door air shower rooms not being able to pass large-sized equipment, and at the same time, the equipment can be quickly sealed after entering, maintaining the cleanliness of the area.
Clean tools and turnover equipment recycling
Sterile turnover carts, stainless steel material buckets, special material pallets, clean tool racks, pharmaceutical molds, etc., after cleaning and sterilization, return to the production process through the air shower room; the used tools can also be transferred through the dedicated channel to the cleaning and sterilization area via the air shower room, forming a clean tool closed circulation, avoiding the contamination of tools entering the core sterile area.
3. Semi-finished products and finished products transfer and outbound scenarios
Covering the entire process of sterile products from semi-finished product processing to finished product outbound, ensuring that the products are always in an ISO 5 level clean controlled environment.
Sterile semi-finished product transfer scenarios
Applicable to intermediate products after sterile liquid preparation, semi-finished products before freeze-drying, semi-formed products after filling, in adjacent core sections such as the preparation room, filling room, freeze-drying room, and lamp inspection room of ISO 5 level. The air shower room serves as a regional barrier, achieving efficient material passage while preventing cross-contamination between different sections, ensuring the cleanliness of the semi-finished products throughout the process.
Clean outbound and storage connection of finished products and packaging
Sterile injections, freeze-dried powder injections, vaccines, blood products, etc., after inner packaging, are transferred from the ISO 5 level finished product temporary storage area through the air shower room to the clean warehouse or outsourcing area. 1. The rapid winding design can be adapted for warehouse forklifts and pallet trucks operations, enhancing the transfer efficiency of large quantities of finished products, and preventing dust and microorganisms from flowing back into the core clean area from the outsourcing area.
2. Special high-value-added biological product exclusive scenarios
For categories with extremely strict cleanliness requirements such as vaccines, biological drugs, and blood products, the washroom is the key logistics facility for their compliant production.
Vaccine production process material purification
Covering all materials such as vaccine strains, inactivating agents, adjuvants, filling packaging materials, and vaccine products, in the ISO 5-level vaccine production workshop. The washroom strictly removes particles and floating bacteria on the materials, meeting the strict GMP standards for vaccine production, and the rapid rolling shutter door is suitable for the large-scale and continuous production logistics requirements of vaccines.
Material transfer in biopharmaceuticals and genetic engineering
Monoclonal antibodies, recombinant proteins, gene therapy drugs, cell therapy preparations, as well as disposable biological consumables and cell culture components, these high-value-added materials have zero tolerance for contamination. Through the washroom purification, contamination can be avoided, preventing product scrapping, and meeting the passage requirements for large consumables and reactor components.
Material cleanliness control for blood products
For blood product-related materials such as plasma raw materials, blood separation equipment, sterile collection tubes, human albumin, immunoglobulin, etc., the purification of the washroom prevents external microorganisms and dust from contaminating blood products, ensuring the biological safety of the products.
3. Linkage scenarios between clean auxiliary areas and core areas
Connecting the clean storage, R&D, and production logistics chains to achieve one-stop clean transfer of materials.
Clean warehouse and core workshop direct connection
The ISO 5-level clean warehouse is directly connected to the sterile production workshop through the rapid winding washroom. The raw materials, finished products, and packaging materials stored can directly reach the production section, reducing intermediate transfer links, reducing pollution risks, and adapting to the efficient operation of storage and logistics equipment.
Interconnection between R&D pilot and large-scale production
The pilot workshop for innovative drugs, biologic similar drugs, sterile R&D experimental areas, and large-scale production workshops, with materials, experimental samples, and small-scale products, through the washroom achieve clean connection, meeting the clean logistics requirements for the linkage of R&D and production.
4. Closed-loop disposal scenarios for compliance waste
Realizing the safe transfer of sterile production waste, avoiding pollutant reflux, and complying with GMP requirements for waste management.
Sterile production waste generated during the process, such as discarded packaging materials, expired semi-finished products, discarded culture media, inactivated biological waste, and testing waste, are placed in sealed clean containers and transferred one-way from the ISO 5-level clean area to the waste storage area or destruction area through the washroom. The rapid winding door can quickly seal the transfer, preventing the pollutants and odors of the waste from spreading to the clean area, achieving compliant closed-loop disposal of waste.
5. GMP verification and compliance testing scenarios
As a core component of the workshop’s clean system, participating in the GMP certification of the pharmaceutical factory, and the re-measurement of cleanliness during annual GMP certification, equipment verification, and air flow organization verification.
During GMP certification of the pharmaceutical factory, annual cleanliness re-measurement, equipment verification, and air flow organization verification, the washroom serves as the core logistics channel. Its cleanliness, sealing performance, air flow effect, opening and closing speed, etc., all need to meet ISO 5-level standards, and is a key facility for verifying the pollution control ability of the clean area and the compliance of material transfer.