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EU GMP Annex 1 Class B Clean Room for Sterile Pharmaceutical Manufacturing

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  • Shipping Timeframes: All orders are processed within 2-5 business days (excluding weekends and holidays). After your order has been processed, the estimated delivery time is before 03 Feb, 2026, depending on customs, Please note that due to high demand, some items may experience longer shipping times, which will be communicated at order confirmation email.
  • Order Processing Time: Please allow 2-5 business days for us to process your order before it is shipped . Orders placed after 16:00 on Fridays, or during weekends and public holidays, will begin processing on the next business day. Processing times may be extended during peak seasons or sales events.
  • Manufacturing Time: Some products needs manufacturing time, the manufacturing process will take approximately 10-30 business days depending on the product. This timeframe may vary depending on the complexity of the product and current demand. but this will be communicated with you during order confirmation.
  • Returns and Exchanges: We offer a 30-day return policy for most items. If you are not completely satisfied with your purchase, you may return it within 30 days of receipt for a refund or exchange. Items must be unused, in their original packaging, and accompanied by proof of purchase. Return shipping costs are the responsibility of the customer, unless the item was damaged or defective upon arrival.
1. What is the size of the EU GMP Annex 1 Class B Clean Room?

The clean room has a size of 12887 m².

2. What materials are used in the construction of this clean room?

The clean room is constructed from high-quality stainless steel (SUS304/201/Q195) and galvanized sheet.

3. What is the weight of the clean room?

The clean room weighs approximately 3000 kg.

4. What certifications does this clean room have?

The clean room is CE and ISO certified, and meets GMP standards.

5. Is the layout of the clean room customizable?

Yes, the clean room features a customizable layout to fit your specific needs.

6. What warranty is provided with the clean room?

The clean room comes with a warranty of 3 years.

7. What are the main applications for this clean room?

The clean room is suitable for sterile drug manufacturing, biotechnology product development, medical device production, research and development laboratories, quality control and testing facilities, and pharmaceutical packaging processes.

8. How does this clean room ensure cleanliness?

The clean room is designed to meet EU GMP Annex 1 standards for cleanliness, which ensures a high level of sterility for pharmaceutical processes.

9. What is the price range for the clean room?

The clean room is priced at US$ 30,000 and above.

10. How easy is it to clean and maintain this clean room?

The clean room is designed to be easy to clean and maintain, ensuring ongoing compliance with cleanliness standards.

11. Is the clean room suitable for biotechnology applications?

Yes, the clean room is ideal for biotechnology product development and other sterile applications.

12. Can this clean room be used for medical device production?

Absolutely, the clean room is suitable for medical device production that requires a sterile environment.

13. What type of functionality does this clean room offer?

The primary functionality of the clean room is to maintain cleanliness in a controlled environment.

14. Is this clean room a single unit or part of a larger installation?

The clean room is sold as a single item but can be integrated into larger systems if needed.

15. What industries typically use this clean room?

This clean room is commonly used in the pharmaceutical, biotechnology, and medical device industries.

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