When it comes to the production of sterile pharmaceuticals, cleanroom classification is fundamental knowledge. However, do you truly understand the characteristics and applicable scenarios of Grades A, B, C and D? Article 14 of the new regulation provides clear definitions, yet definitions are static while practical applications are dynamic. Today we will thoroughly discuss this topic.

I. Official Definitions

Original text of Article 14 of the new regulation:

“The cleanrooms required for sterile pharmaceutical production are divided into four grades as follows:

Grade A: Critical areas for high-contamination-risk operations, where unidirectional airflow shall be maintained.

Grade B: For high-contamination-risk operations, Grade B serves as the background environment for Grade A cleanrooms (excluding isolators). The differential pressure of Grade B cleanrooms shall be continuously monitored.

Grades C and D: Cleanrooms for operational steps with relatively low contamination risks in sterile pharmaceutical production.”

Concise memory formula: Grade A = Core Operation Zone, Grade B = Supporting Background Zone, Grades C & D = Peripheral Support Zones.

II. Grade A: Highest Grade, Absolute Critical Zones

The core keyword of Grade A is “unidirectional airflow”.

Concept: Supply air filtered by HEPA filters flows downwards in an even, parallel pattern to remove particles and microorganisms generated during operations. The airflow velocity is generally maintained at around 0.45 m/s to guarantee airflow remains undisturbed before reaching the working surface.

Typical application scenarios for Grade A:

• Aseptic filling areas

• Internal working zones of open isolators

• Operating areas of open RABS

• High-risk operation points such as stopper washing and hopper feeding

A confusing distinction exists between Grade A inside isolators and Grade A inside RABS/open cleanrooms, specified in Articles 25 to 27 of the new regulation:

• The background environment of open isolators shall be at minimum Grade C

• The background environment of closed isolators shall be at minimum Grade D

• The background environment of RABS shall be at minimum Grade B

Therefore, it is insufficient to simply refer to “my Grade A area”; the background grade must also be specified.

III. Grade B: The Protective Barrier for Grade A

The definition of Grade B: “For high-contamination-risk operations, Grade B serves as the background environment for Grade A cleanrooms (excluding isolators).”

Key points of this clause:

1. Excluding isolators – isolators can adopt Grade C or D as background without requiring Grade B.
2. Background zone – the primary function of Grade B is to protect Grade A from contamination, so differential pressure must be continuously monitored to ensure air flows outwards from Grade B and prevents reverse flow.
3. High-contamination-risk operations – Grade B background is only required for high-risk operations using RABS or open cleanrooms, not all production activities.

Personnel gowning requirements for Grade B are the most stringent: sterile coveralls, double gloves, goggles, etc., are mandatory. Separate changing rooms shall be designated for personnel entering/exiting Grade B zones (Article 105 of the new regulation).

IV. Grades C and D: Low-Risk Zones That Cannot Be Neglected

Definition of Grades C and D: “Cleanrooms for operational steps with relatively low contamination risks.”

Note the wording “relatively low” rather than “zero risk”. Grades C and D remain integral parts of sterile production with merely controllable risks.

Typical applications:

• Grade C: Formulation areas for non-terminally sterilized products, peripheral environments of BFS equipment, late-stage changing rooms, etc.

• Grade D: Formulation areas for terminally sterilized products, material preparation areas, cleaning areas, etc.

There are obvious differences in environmental monitoring standards between Grade C and D. For airborne particles under dynamic conditions: Grade A requires virtually zero particles ≥5.0μm; Grade B limits particles ≥5.0μm to no more than 29 per cubic meter; standards for Grades C and D are far more lenient.

V. Common Confusion: Relationship Between Grades and Equipment

Many people ask: “Which grade should the sterilizer be placed in? Which grade for the RABS?” This question itself is incorrect.

The correct framing: “Which grade corresponds to a specific part of the sterilizer (e.g., the opening where vials are exposed)? What is the background grade of the RABS?”

Equipment does not equate to a fixed cleanroom grade. Different sections of a single piece of equipment may correspond to distinct grade requirements.

Article 137 of the new regulation provides detailed risk assessment guidance for isolator background environments, covering the following factors:

• Microbial decontamination procedures
• Automation level
• Impact of glove operations on first-pass air at critical process points
• Risks arising from compromised barriers or glove integrity
• Material transfer systems in use

VI. Airflow Design: Unidirectional vs. Non-Unidirectional Flow

Article 22 of the new regulation stipulates: Airflow pattern studies shall be performed for unidirectional airflow systems; such studies shall also be conducted for non-unidirectional airflow systems when necessary.

Grade A zones must adopt unidirectional airflow. Airflow pattern studies shall be visualized to verify the airflow design does not cause contamination retention or cross-contamination.

Grade B zones typically adopt turbulent or mixed airflow. Large-area Grade B zones would incur excessive energy consumption and costs with full unidirectional flow, yet turbulent airflow designs still require validation to confirm effective contaminant removal.

VII. Differential Pressure Control: Invisible Contamination Barriers

Article 23 of the new regulation: Differential pressure monitoring points shall be determined based on Contamination Control Strategy (CCS). Differential pressure indicators shall be installed at minimum between adjacent different-grade zones and between isolators and their background environments.

The essence of differential pressure lies in airflow direction. Grades A and B shall maintain positive pressure relative to external areas to ensure air flows outward only and block external contamination infiltration.

A widespread misconception: higher differential pressure equals better protection. Excessively high differential pressure causes difficult door operation, excessive stress on sealing components and increased energy consumption. A reasonable differential pressure range (typically 10–15 Pa) shall be determined via risk assessment of adjacent zones, with continuous monitoring implemented.

VIII. Practical Suggestions for Rational Grade Allocation

1. Avoid over-grading: Grade A is not mandatory for all operations. Isolator technology allows certain operations to be carried out under lower background grades, cutting costs while mitigating contamination risks.
2. Prioritize airflow organization: Cleanroom grades represent static standards, while airflow organization governs dynamic contamination control. Two Grade B zones with different airflow designs can deliver vastly different contamination control performance.
3. Align grades with process risks: Process risk assessment results shall determine which grade each operation is assigned to. Grades cannot be arbitrarily set before process planning.
4. Regular re-evaluation: When product formulas, production processes or facility equipment are modified, the original cleanroom grade layout shall be reassessed for rationality.

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I. Working Principle: Resolving the Cold Air Dilemma Through “Pulsation”

The core design philosophy of the pulsating vacuum sterilizer lies in the multiple alternating vacuum-steam cycles that thoroughly evacuate cold air from the sterilization chamber, thereby creating an ideal sterilization environment for saturated steam. The complete operational workflow can be divided into four stages:

1. Pre-Vacuum Stage

Upon initiation of the sterilization program, the vacuum pump first evacuates air from the sterilization chamber, establishing a preliminary negative pressure state. This step lays the foundation for subsequent pulsation cycles and initially reduces the gas content within the chamber.

2. Pulsation Stage (Technical Core)

This stage represents the key differentiator of the pulsating vacuum sterilizer from other sterilization modalities. The system executes 3 to 5 alternating cycles of “vacuum extraction—steam injection—re-vacuum extraction”. Each pulsation functions akin to a “respiration” process: vacuum suction progressively evacuates cold air from within packaged items, elongated lumens, and dead corners of the chamber; subsequently injected high-temperature steam rapidly fills these spaces. Through multiple cycles, the cold air elimination rate can exceed 99%, fundamentally resolving the problem where steam is blocked by cold air and cannot adequately contact sterilization surfaces.

3. Sterilization Stage

Once the cold air within the chamber has been substantially eliminated, the equipment injects high-temperature saturated steam (typically set at 121°C or 134°C) and maintains it at the corresponding pressure for a specified duration. Upon contact with item surfaces, the saturated steam releases substantial latent heat, causing rapid denaturation and coagulation of microbial proteins, thereby achieving sterilization efficacy against all microorganisms, including heat-resistant spores.

4. Drying Stage

Following the completion of sterilization, the system reactivates the vacuum pump to evacuate steam from the chamber and introduces filtered dry hot air. This step can rapidly remove residual moisture from item surfaces and interiors, effectively preventing the “wet pack” phenomenon and ensuring that sterilized items maintain their sterile state during storage.

II. Core Advantages: Demonstrating Technical Value Across Six Dimensions

Based on the aforementioned working principles, the pulsating vacuum sterilizer exhibits significant technical advantages in industrial applications:

1. Exceptional Penetration Capability, Compatible with Complex Devices

Multiple vacuum pulsations can effectively penetrate joint clearances of precision instruments, elongated channels of lumen-type devices, and internal structures of porous materials such as fiber products and filtration media. This performance, unattainable by traditional gravity-displacement sterilizers, makes it an ideal choice for sterilizing structurally complex industrial devices.

2. Reliable Sterilization Efficacy with High Safety

Due to the thorough elimination of cold air, saturated steam can distribute uniformly throughout every corner of the sterilization chamber, resulting in more consistent sterilization temperature distribution. This characteristic significantly enhances the reliability of eliminating heat-resistant spores (such as Geobacillus stearothermophilus), substantially reducing the risk of sterilization failure.

3. Excellent Drying Performance, Facilitating Storage

The terminal vacuum drying program, combined with hot air injection, can reduce surface moisture content to safe levels within a short timeframe. Thoroughly dried sterilization packs are less susceptible to secondary contamination by external microorganisms during storage and transportation, effectively extending the shelf life of sterile items.

4. Broad Applicability Range

From bare metal devices and packaged industrial goods to bottled liquids, glassware, rubber products, and cleanroom garments, the pulsating vacuum sterilizer can accommodate diverse requirements. Its flexible program settings allow optimization of sterilization parameters for different materials and loading configurations.

5. Efficient Sterilization Cycle, Enhanced Turnover Rate

Compared to gravity-displacement sterilizers that rely on steam sinking to displace cold air, the pulsating vacuum method offers faster temperature rise and shorter overall sterilization cycles. In large-scale production enterprises, this advantage translates directly into improved device turnover efficiency, helping alleviate supply-demand pressures on production lines.

6. High Degree of Intelligence, Facilitating Quality Management

Modern pulsating vacuum sterilizers are generally equipped with PLC control systems, enabling automatic program execution, real-time parameter monitoring, fault alarm, and sterilization data recording. Some high-end models also support networking capabilities, facilitating traceability management of sterilization quality for enterprises and compliance with ISO quality management systems and GMP specifications.

III. Application Scenarios and Industrial Value

The technical characteristics of the pulsating vacuum sterilizer determine its irreplaceability in multiple critical domains:

• Pharmaceutical Industry: Undertakes terminal sterilization tasks for culture media, glassware, cleanroom garments, and production tools, serving as an essential defense line against product contamination.
• Food Industry: Utilized for commercial sterilization of canned foods, condiments, and packaging materials, ensuring food safety and shelf life.
• Scientific Research Laboratories: Provides reliable biosafety assurance for biological experimental equipment, petri dishes, glass instruments, and waste treatment.
• Precision Manufacturing: Satisfies stringent requirements for cleanliness and sterile environments for electronic components, optical devices, and composite materials.

Through its technical pathway of “multiple pulsations, thorough cold air elimination, saturated steam sterilization, and vacuum drying,” the pulsating vacuum sterilizer has successfully resolved sterilization challenges for complex devices and packaged items. Its exceptional penetration capability, reliable sterilization efficacy, and efficient operational performance have established it as a cornerstone of modern industrial sterilization systems. As industrial technology continues to evolve and quality control standards progressively elevate, pulsating vacuum sterilization technology will undoubtedly play an increasingly vital role in safeguarding product quality and enhancing sterilization standards. For production enterprises, a thorough understanding of its working principles and standardized operation constitute the prerequisite and foundation for fully leveraging the technical advantages of this equipment and fortifying the sterile defense line.

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1. Core Sterilization Principle of Pulsating Vacuum Sterilizer

The pulsating vacuum sterilizer uses saturated high-temperature steam as the sterilization medium and completes the sterilization operation relying on the pulsating cycle of repeated vacuum pumping and steam injection. Its core principle is divided into four processes, which are fully controllable and highly stable.

The first is the pulsating exhaust process. After the equipment is started, the vacuum pump repeatedly extracts air from the sterilization chamber, and injects steam intermittently at the same time. The cold air in the chamber is replaced through multiple pressure rises and falls. Compared with the single exhaust mode of ordinary sterilizers, this method can completely remove residual air in gaps of items, inner cavities of pipelines and interlayers of stacked materials, fundamentally solving the problem of incomplete sterilization caused by cold air retention. The second is the heating and pressurization process. After exhaust, saturated steam is continuously introduced into the closed chamber to raise the temperature and pressure inside the chamber. The conventional sterilization temperature can reach 121℃ to 134℃. The high-temperature and high-pressure environment can destroy the protein and nucleic acid structures of microorganisms, killing bacteria, spores, fungi and other various microorganisms.

Furthermore, there is the constant temperature and pressure maintenance sterilization process. The equipment accurately maintains the set temperature and pressure, and adjusts the pressure holding time according to the material and density of the sterilized items, ensuring that steam fully penetrates porous materials, tubular appliances and stacked packages to achieve all-round and dead-angle-free sterilization. The last is the vacuum drying and pressure relief process. After sterilization, the moisture in the chamber is extracted again, and the residual water on the surface and inside of the items is dried in a negative pressure environment to ensure that the sterilized items are dry without moisture residues. Finally, the pressure is slowly relieved to restore atmospheric pressure, completing the entire sterilization process. The whole process runs automatically with precise parameter control, adapting to the sterilization needs of various heat-and moisture-resistant industrial materials.

2. Core Technical Advantages of Pulsating Vacuum Sterilizer

Relying on its unique working principle, the pulsating vacuum sterilizer has significant differentiated advantages in application, adapting to the requirements of industrialized and standardized aseptic operations.

1.Thorough air removal and strong steam penetration, suitable for sterilizing heavy packages, tubular cavities and porous structural materials, solving the pain point of insufficient steam penetration in traditional sterilization.
2.Negative pressure drying after sterilization, with low moisture content of items, no need for secondary drying, direct use, and greatly improved operation efficiency.
3.Gentle pressure fluctuation in the chamber, no deformation or rupture of closed containers, suitable for sterilizing various sealed packages and glass pressure-bearing containers.
4.Physical steam sterilization throughout the process, no chemical reagent residues, green and environmentally friendly, adapting to industries with strict cleanliness requirements such as food and pharmaceuticals.
5.High degree of automation and traceable operation data, in line with industrial standardized production specifications.

3. Main Non-Medical Application Scenarios of Pulsating Vacuum Sterilizer

3.1 Biopharmaceutical Industry

The biopharmaceutical industry is one of the core application fields of pulsating vacuum sterilizers. The pharmaceutical industry has extremely high requirements for aseptic standards, and even a trace amount of miscellaneous bacteria contamination will cause the scrapping of the entire batch of raw materials and finished products. In GMP-standardized pharmaceutical workshops, this equipment has a wide range of application scenarios. It is mainly used for the sterilization of textile work clothes such as special aseptic work clothes, protective caps and protective shoes in clean workshops. It is also suitable for the sterilization of production equipment accessories such as liquid distribution pipelines, filling equipment, mixing containers and sampling appliances. In addition, materials such as microbial fermentation media, raw material drug storage containers and test glassware also need to be sterilized by pulsating vacuum sterilizers to ensure the entire process of pharmaceutical production is aseptic and pollution-free, meeting the strict quality control standards of the pharmaceutical industry.

3.2 Scientific Research and Experimental Institutions

Universities, biological research institutes and third-party testing laboratories are generally equipped with pulsating vacuum sterilizers to serve experimental work such as microbial research, biological cultivation and physical and chemical testing. In laboratories, conventional experimental utensils such as glass petri dishes, pipettes, beakers and reagent bottles, as well as metal sampling tools and clamping instruments, need regular sterilization. Strain media and cultivation substrates used in microbial experiments need to be prepared in an aseptic environment. This equipment can accurately control the sterilization temperature and time to ensure the aseptic property of the media. At the same time, items such as experimental animal feeding cages, special bedding and experimental protective work clothes can also be sterilized by this equipment, avoiding the interference of miscellaneous bacteria in the experimental process, ensuring the authenticity and reliability of experimental data, and building a pure experimental environment for biological research and physical and chemical testing.

3.3 Food Processing Industry

The food processing industry focuses on production hygiene and storage safety. Pulsating vacuum sterilizers are mostly used for the sterilization of food production auxiliary materials and heat-resistant appliances. On the one hand, they are used for the sterilization of heat-resistant food packaging materials, such as high-temperature resistant plastic packages, sealed glass bottles and food storage containers, killing microorganisms on the surface of packages and extending the shelf life of food. On the other hand, clean cloth, dust-proof work clothes, processing auxiliary tools and pipeline accessories in food processing workshops can all be sterilized by this equipment. In addition, in the processing of canned food and prepared food, some heat-resistant auxiliary materials and storage containers can also be sterilized by pulsating steam. The whole process has no chemical residues, conforms to food safety production specifications, and takes into account both sterilization effect and edible safety.

3.4 Beauty and Daily Chemical Industry

Beauty and daily chemical products directly contact human skin, and have strict requirements for the aseptic production environment. Pulsating vacuum sterilizers are mainly used in daily chemical production workshops to conduct in-depth sterilization of filling pipelines, storage tanks and sub-packaging appliances for skin care products and cosmetics, eliminating bacteria, molds and other microorganisms on the surface of appliances. At the same time, clean protective clothing, production wiping cloth and special auxiliary work clothes in the workshop also need regular sterilization. The mild sterilization mode of this equipment leaves no harmful substances, can adapt to the clean production requirements of the daily chemical industry, avoid microbial contamination of products during the production process, and ensure the stable quality of beauty and daily chemical products.

3.5 Animal Husbandry and Breeding Industry

Large-scale farms, animal husbandry breeding bases and pet breeding institutions need to do a good job in disinfection and control of the breeding environment to block the spread of pathogens. Pulsating vacuum sterilizers are suitable for the sterilization of special appliances for animal husbandry and breeding, including breeding feeding tools, sampling and testing instruments, breeding auxiliary appliances and isolation protective supplies. At the same time, clean cloth, protective pads and high-temperature resistant breeding consumables in breeding workshops can be sterilized centrally. For breeding substrates and storage containers used for livestock and poultry breeding, this equipment can also complete aseptic treatment, effectively reducing the probability of livestock and poultry infection, optimizing the breeding hygiene conditions, and promoting the development of large-scale and standardized animal husbandry.

3.6 Other Light Industry Manufacturing Industries

In addition to the above industries, pulsating vacuum sterilizers are also widely used in many light industry fields. For example, in the clean textile industry, they are used for the sterilization of special aseptic cloth and industrial protective fabrics; in the new material research and development industry, they are used for the sterilization and disinfection of high-temperature resistant industrial consumables and experimental molds; in the environmental protection processing industry, they complete the aseptic processing pretreatment of environmental protection paper materials and non-woven products. The diversified adaptability makes this equipment a general core equipment for aseptic production in the light industry.

4. Industry Development Summary and Prospect

With the continuous improvement of production standardization and cleanliness in various industries, the coverage of aseptic control continues to expand, and the demand for high-quality sterilization equipment increases year by year. With its mature pulsating vacuum sterilization technology, wide material adaptability and green and safe sterilization method, the pulsating vacuum sterilizer has broken through the application limitations of traditional sterilization equipment and occupied an irreplaceable position in pharmaceuticals, scientific research, food, daily chemicals, animal husbandry and other industries.

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Equipment Selection for Pharmaceutical Manufacturing: Align URS with Risk Management to Avoid 90% of GMP Compliance Issues

When selecting pharmaceutical manufacturing equipment, integrating the User Requirement Specification (URS) with risk management from the start is the most effective way to prevent 90% of common GMP compliance issues. Here’s how to embed compliance into your requirements:

1.Contamination Control Design
The URS must define critical design requirements such as crevice-free construction, full drainability, material specifications, and the need for Clean-in-Place (CIP) and Sterilize-in-Place (SIP) capabilities. These built-in features minimize risks of microbial and particulate contamination at the design stage.

2.Verifiability & Qualification Requirements
The URS should specify test points and port provisions for temperature distribution mapping, pressure testing, and flow verification. This ensures the equipment is designed to successfully pass Installation Qualification (IQ) and Operational Qualification (OQ).

3.Data Integrity Compliance
The URS must mandate built-in data integrity features: automated data logging, audit trails, tamper-proof controls, and traceable data export functions. Addressing these requirements technically at the beginning eliminates the high cost and risk of relying on procedural workarounds later.

4.Supplier Qualification & Documentation
The URS or technical agreement must require the supplier to provide complete documentation: material certificates, welding records, calibration certificates, Factory Acceptance Test (FAT) support, and validation documentation packages. This prevents costly delays and deviations during IQ/OQ due to missing records.

5.Lifecycle Maintenance Strategy
The URS should outline requirements for calibration schedules, preventive maintenance plans, and revalidation support for spare parts. This ensures long-term compliance and controls the total cost of ownership throughout the equipment’s lifecycle.

The Core of Equipment Selection is Building a Validatable, Long-Term Compliant System.
Poor planning at the selection stage often leads to post-purchase compliance costs that far exceed the original equipment price.

How are these requirements defined in your URS?
Contact us today. We can assist you in refining your URS documentation and provide full validation support for our equipment.

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1. First, Understand: What Exactly is GMP? (In One Sentence)

GMP stands for Good Manufacturing Practice. Its official translation is “Pharmaceutical Production Quality Management Specifications” (Key point: Don’t miss the word “Quality”). It’s not a single-step manual, but a full-process rule covering pharmaceutical raw materials, production, testing, and storage. Its core is to ensure drugs are safe, effective, and of stable quality.

2. GMP’s “Rule Levels”: Two Layers, Easy to Remember

GMP has two layers of rules, which are easy to remember:

1. Legal Layer: Hard rules set by countries/regions. Human drugs and veterinary drugs have their own exclusive bases; non-compliance is illegal.

2. Core Implementation Layer: For example, the EU’s EudraLex Volume 4. Although it seems like a practical manual, it actually has mandatory binding force and must be strictly followed during regulatory inspections.

3. GMP’s “Six Core Pillars”: None Can Be Missing, Otherwise Drug Quality Will Be Out of Control

This is the core of GMP. The six key links are indispensable, broken down in plain English as follows:

1. Pharmaceutical Quality System (PQS): The “quality steward” that coordinates and controls the quality of the entire process.

2. Personnel Management: Operators and inspectors must be properly trained and operate standardizedly.

3. Premises and Equipment: Factories must meet standards, and machines must be regularly inspected, maintained, and disinfected to avoid drug contamination.

4. Material and Product Management: Expired or unqualified raw materials are prohibited, and finished products must be properly stored to avoid wrong material use.

5. Documentation Management: All operations must be recorded to facilitate subsequent problem tracing.

6. Production and Quality Control (QA/QC): Produce in accordance with rules, with special personnel responsible for testing (QC) and supervision (QA) to ensure each batch is qualified.

4. “Part Two” and “Annexes” in GMP: Specifically Solve “How to Do It”

Both are simple; let’s clarify them separately:

1. Part Two: Specifically manages active pharmaceutical ingredients (APIs), focusing on controlling API processes, purity, and impurities.

2. Annexes: Practical detail manuals that teach you how to do it specifically, such as:

– Annex 1 (Sterile Manufacturing): Guides the production of sterile drugs (e.g., infusions) to avoid bacterial contamination;

– Annex 11 (Computerized Systems): Regulates the computer management of production data to ensure it is not tampered with;

– Annex 15 (Validation): Confirms that equipment and processes are qualified to produce qualified drugs.

5. GMP Is Not an “Isolated Rule”: It Is Aligned with International Standards and Has a Unified Core Logic

GMP is not isolated; it is aligned with international standards. For example, the core references are Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) from the ICH organization.

The core concept is “Quality by Design (QbD)”: Drug quality is not detected at the end, but built into the process from the source when designing processes and formulating rules.

6. Veterinary Drug GMP: A Separate Set of Rules, But the Core Logic Is the Same as Human Drugs

Veterinary drug GMP is both different from and consistent with human drug GMP:

1. Reason for Separation: The EU’s Regulation (EU) 2019/6 separated it independently. It’s not a lower standard, but because veterinary drugs have differences in species metabolism and dosage, and need to consider the food chain safety of food-producing animals, requiring precise control.

2. Core Consistency: The underlying logic of quality systems, deviation management, Corrective and Preventive Actions (CAPA), and data integrity is the same, all to ensure drugs are qualified and safe.Summary: GMP is a full-process quality rule for drugs. Its core is to ensure quality is well-controlled and prevent unqualified drugs from entering the market. The above is explained in plain English, making it easy for beginners to understand.

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