Zonsteel – Your Proficient Pharmaceutical Clean Room Manufacturer in China

Choose to purchase your pharmaceutical cleanroom at Zonsteel. Our pharmaceutical cleanroom includes all enclosure material like sandwich panel walls, sandwich panel ceilings, floors, doors, windows and more. We pay attention to every detail of your pharmaceutical cleanroom to ensure high quality.

We specifically design pharmaceutical clean rooms to minimize materials and process contamination by removing contamination sources. Zonsteel can provide a pharmaceutical cleanroom that conforms to all national and international standards. Thus, you can find the right product for your application.

You can purchase a pharmaceutical clean room with an economical and modular design. Thus, you can ensure competitive prices. We also manufacture pharmaceutical clean rooms with high efficiency, convenient use, and flexible format.

Whether you need a pharmaceutical cleanroom to manufacture sterile and non-sterile medical products, choose Zonsteel as your manufacturer. With our expertise, we can surely understand your needs and requirements.

We are equipped with a universal testing machine, MPPS testing line for purification equipment, and more. Therefore, you can assure a high-quality product. You can also guarantee that we have certifications from ISO and other international standards.

Aside from the pharmaceutical clean room, we are also experts in manufacturing cleanroom lab, cleanroom airlock, GMP clean room, hospital clean room, and semiconductor clean room. Zonsteel offers cleanroom equipment inlcuded hospital door, hospital room doors, operating room door, surgical scrub sink, hospital walls, air shower tunnel, open air shower, dynamic pass box, static pass box, glasfloss air filters, stainless steel mesh air filter, and more.

Zonsteel also guarantees thorough inspection before shipping. We guarantee budget-friendly prices, fast delivery, and full support on installation, repair, and maintenance. Thus, we can provide you a full range of pharmaceutical clean rooms.

You can also guarantee the best after-sales services. Please be assured that Zonsteel will accommodate your needs 24/7. Choose Zonsteel as your primary pharmaceutical cleanroom manufacturer and supplier.

Contact us for your next pharmaceutical cleanroom projects!

Pharmaceutical Clean Room: The Ultimate FAQ Guide

Learn more about the pharmaceutical clean rooms with this guide.

We prepare some questions and answers for you.

What is a Pharmaceutical Clean Room?

The pharmaceutical clean room (area) takes particles and microorganisms as the main control objects.

At the same time, the temperature, humidity, pressure difference, illuminance, noise and other parameters of the pharmaceutical clean room should be controlled to meet the process requirements of all aspects of drug production.

So as to achieve no peculiar smell in the ambient air and no gas that hinders the quality of medicines and human health.

The pharmaceutical meets requirements of GMP, ensure a scientific and strict sterile drug production environment, process, operation and management system.

To minimize all possible and potential biological activity, dust, pyrogen pollution, and to produce high quality, hygienic and safe pharmaceutical products.

Through in-depth research on the production environment of biopharmaceutical customers and accumulation of engineering experience, Zonsteel has a clear understanding of the key to environmental control in the production process of biopharmaceuticals.

Energy saving is the priority of our system plan. It meets the requirements of GMP and ISO14644, IEST, EN1822 international standards. Apply innovative energy-saving technology to environmental solutions.

Why You Need a Pharmaceutical Clean Room?

You will need a pharmaceutical clean room for producing hygienic medical items. It has wide use in the pharmaceutical industry.

Pharmaceutical clean rooms are completely oxygenated with purified air. It guarantees a clean production area. But for non-hygienic medical items production, require higher maintenance.

The pharmaceutical production workshop has strict requirements, and the production workshop must meet the purification requirements of the GMP before production can be carried out.

GMP requires that the production of preparations, fine baking packages of raw materials, raw and auxiliary materials used in preparations and packaging materials directly contacting drugs should be carried out in clean rooms.

What Industries that Need a Pharmaceutical Clean Room?

1. Medicinal Industry
2. Pharma Companies
3. Hospital
4. Field Hospital
5. Mobile Hospital
6. Clinical Research
7. Synthetic Supplies
8. Biopharmaceutical Field
9. GMP Pharmaceutical Workshop
10. Class 10,000 Clean Room for Medical Equipment
11. Biomedical

What Pharmaceutical Clean Room Types Should You Consider?

Each pharmaceutical clean room type meets ISO 14644-1. Consider the one with purified corridor style.

Here are the top 6 types:

Pharmaceutical Modular Clean Room-This type is simple and quick to install. It provides upgraded sterility levels and low-cost operations.

Pharmaceutical Clean Room Partitions-Popular for their high-tech designs, superior chemical resisting, fast setup, steel frames, panel cones, and entrenched wiring.

Pharmaceutical Portable Clean Room-Perfect for medical and pharmaceutical industries. It is known for its high purity level. Also easy to install and easy to locate.

Prefabricated Pharmaceutical Clean Room-For an extreme sterile area, a prefabricated pharmaceutical clean room is a better option. It provides a full structural line, modular structure, and simple reform.

Pharmaceutical GMP Turnkey Clean Room-It offers effortless and quick installations. Plus, it is preferred for dust-proof functions.

Pharmaceutical Sandwich Panels Clean Room-Constructed using the best quality materials. It guarantees ultimate durability and reliability.

What Might Cause Contamination in a Pharmaceutical Clean Room?

A top concern of a pharmaceutical clean room is bacterial contamination. Technology is not enough to measure bacterial contaminations exactly. But, it can limit the probable bacteria or aerial impurity.

The workforce in the pharmaceutical clean room is also one cause.  The amount of staff is the greatest cause of bacterial contaminations and aerial impurity. So, staff limiting and correct clothing are required.

Pharmaceutical clean rooms are made with filter devices to stop bacterial contaminations.

Note: Pharmaceutical Clean Rooms controls contamination to sustainable levels. They are not capable to eliminate it fully.

What Makes a Pharmaceutical Clean Room a “Clean Room”?

“Clean Room” because they maintain higher cleanliness levels in the entire area.

Learn the three things that help pharmaceutical clean room remain clean.

1. Staff limitations and effective methods in operating clean room.
2. Cleanliness in clean room equipment and interior areas.
3. Airflow quality and control are set up all over the clean room.

What Involves in Using a Pharmaceutical Clean Room?

Maintain and use pharmaceutical clean room in a precise manner. That will be the most practical way to maintain airflow quality. Doing this matter involves:

1. Constant air filters control, air motions monitoring, and nonstop revalidations.
2. Reducing the probable impurity amount that flees from the pharmaceutical clean room.
3. Efficient space and equipment sanitation.
4. Constant space and tools maintenance.
5. Rigorous directive entry for only professional, limited staff.

What is Correct Pharmaceutical Clean Room Set Up?

There are standards in setting up a pharmaceutical clean room. The ISO Group provides these standards.

Pharmaceutical clean room installations begin with structure point. In this point, examine first the clean room location and what way it will be used. Manufacturers should have thorough discussions with users for this point.

However, the pharmaceutical clean room designs are based on your industry. Setting up a pharmaceutical clean room involves several elements.

When setting up a clean room, below are the key points to ponder:

High-Efficiency Particulate Air (HEPA) Filter –HEPA filter can filter 0.3 microns particles or smaller. It really supports impurities prevention and removals. It makes the entire area fresher, away from hazardous contaminants. It also helps people in the area be more comfortable.

Dangerous Substances –Use a particular waste air treatment and dismissive air-pressure systems. It is required if your pharmaceutical clean room has dangerous materials. Also, wear protective gowns when entering a clean room. Set apart the entryway and exits for extra protection.

Ventilating System –This is needed to support airflow qualities and restore consumed operations. Ventilation is always energy-consuming so you will need further space. The extra space is used for cooling unit parts. Ventilation also requires noise mufflers, larger air corridors, huge inlet and outlet stacks, and generator back-ups.

Air Enforcement –Pharmaceutical clean rooms must have higher air enforcement. This will stop harmful wind penetrations. Air pressure also forbids enforcement changes that could harm the whole process.

Humidity & Temperature Control –Always consider humidity and temperature control for pharmaceutical clean rooms. It can help the clean room equipment and materials to stay in reliable conditions. Moreover, the humidity able to stop interior surface erosion and remove fixed electricity. These 2 are the most important factors you should consider for clean room setup.

Laundry and Showers Amenities –You may require a disinfection basis for laundry and showers amenities, all depends on your materials and demands. For this requirement, you should consider high-risk and plumbing waste analysis.

Construction Design –Overall construction design is important for a pharmaceutical clean room. You need to sustain a steady airflow within the clean rooms, therefore, there must a clear path for air. If there’s no clear path, there will be a higher risk of air particles. It is very dangerous if you missed considering construction designs.

Interior Surface Materials –Bring materials that are not prone to foreign speck and airborne impurities. Interior surface materials should be malfunction resistant. Makes sure all materials match your sanitation products, so you’ll be worry-free after cleaning.

Measuring Tools –Collect the best-quality measuring tools. In a pharmaceutical clean room, the temperature, air movements, cleanliness, and humidity should be measured correctly.

High-Quality Lighting –Avoid dim lights in a clean room because you cannot sanitize the area accurately. Consider a much brighter one, static, and consistent.

Electrodynamic Issue –This is a safety material used to avoid likely destruction. Consider this one for extra protection in the pharmaceutical clean room.

How to Do Quality Control of Pharmaceutical Clean Room Project in Zonsteel?

Material Quality Control-When purchasing raw materials, require material certificate and inspection report from supplier

Factory Quality Control-Zonsteel’s core technical team is composed of industry veterans. It has introduced advanced production lines and finished product testing lines, specializing in the production of purification equipment, primary, medium, high-efficiency and ultra-high-efficiency filter products and other cleanroom enclosure materials used in high-end clean rooms. Zonsteel’s inspection production line uses scanning inspection according to EN1822-4 requirements, using the US TSI 7110 particle counter to detect the particle size to 0.1um.

At the same time,Zonsteel introduce the Italian PRIMA POWER flexible sheet metal production line, which is integrated into metal cutting, folding and punching. High-quality raw materials, advanced production lines and testing lines provide guarantee for Zonsteel excellent product quality.

Transport Quality Control-Before the material and equipment shipping, be well packed and seaworthy. Normal packing is wooden and steel pallet.

On-Site Storage-When the material and equipment arrives at the site, Zonsteel will help on storage area plan, and take protective measures according to weather and cleanliness.

Material Inspection-On-site inspection of materials according to material list and specification.

Construction Quality Control-During the installation process, you need to fill in an intermediate checklist to control the quality of related assembly joints, such as bolt joints, welding, etc.,

Equipment Inspection-The assembled equipment (such as power distribution cabinet) must be inspected in terms of appearance, connection points and other related technical requirements.

Instrument Calibration-The installed instrument must be calibrated for accuracy, and relevant connection must be made.

Operating Procedures-During the construction process, relevant equipment, instruments and pipelines must be arranged and the relevant progress must be controlled.

Static Management-Implement personnel, vehicle, and papers management in accordance with the owner’s specifications.

Dynamic Management-The construction site shall be inspected, and recorded.

Safety Management-Agreement to organize construction, lifting, fire, special operations.

Environmental Sanitation-6S environmental sanitation management.

Police Service Management-Documents control processing, In and out plant control.

Personnel Management-Uniform construction vest and helmet specification

What Temperature and Relative Humidity Is the GMP Pharmaceutical Clean Room?

It depends on the production process, The general temperature is 18 ℃ ~ 24 ℃ and the relative humidity is 45% ~ 65%. Also based on the fact that the operators wearing clean working garment do not feel discomfort.

What Are the Cleanliness Requirements of the GMP Pharmaceutical Clean Room Workshop?

Standard for Airborne Particles in clean Areas (Detected by dust Particle Counter)

Dynamic grade standard for microbiological monitoring in clean areas (using plankton sampler)

– Cleanliness Class A

Cleanliness Class A is used in high-risk operation areas, such as filling area, rubber stopper area, open packaging container area and aseptic assembly area.

The unidirectional flow area and the working area must have uniform air supply, with wind speed 0.36m/s ~ 0.54m/s.

Confirmed Grade A area, the sampling volume of each measuring point shall not be less than 1m3. The cleanliness is ISO4.8 grade, and the concentration of ≥ 5.0µm suspended particles is taken as the limit standard.

The length of the sampling tube should be short, to avoid the sedimentation of particles ≥ 5.0µm, which will affect the test results. Unidirectional flow should be sampled using isokinetic sampling.

– Cleanliness Class B

Cleanliness class B is used in the background area for Cleanliness Class A areas. The static cleanliness is ISO5 grade.

– Cleanliness Class C and D

Grade C and D are used in areas with low process requirements for aseptic drug production. Level C static and dynamic are ISO7 and ISO8 respectively. Class D static is ISO8.

How to Do Daily Dynamic Monitoring of Pharmaceutical Clean Room?

-After the production is finished and the operators leave the clean room for 15-20 minutes, the cleanliness of the clean room shall reach the static standard.

-Daily dynamic monitoring items: cleanliness, temperature, relative humidity, pressure gradient, etc.

How to Do Dynamic Monitoring of Microorganisms of Pharmaceutical Clean Room?

Daily dynamic monitoring methods for microorganisms: sedimentation bacteria method, quantitative airborne bacteria sampling method, surface sampling method, etc.

How to Design and Decorate the GMP Dust-free Pharmaceutical Clean Room?

-To avoid crack caused by temperature and vibration, the wall, ceiling and floor must be proper installed.

-The indoor materials must be mildewproof and moisture-proof. Must be inorganic materials with dense surface, no water absorption and no water storage.

-Formalin is corrosive and chalking to general paint. So consider synthetic resin as a wall coating.

-For convenient cleaning reduce dust accumulation, room interior materials must be dense and flat. Use wall corner must be arc 20x50mm, for vacuum cleaning and wet cleaning.

-Interior materials must be non-combustible, and should have a certain electrical conductivity, to prevent electrostatic accumulation caused by accidents.

-The floor must be with good abrasion resistance and impact resistance.

-The floor is also required not to fall off, no crack, durability, water resistance, alkali resistance and moisture-proof, easy to clean.

-Pharmaceutical clean room workshop no window or minimize window sizes. Use good airtight window, and flush mounted with wall.