Clean room manufacturing for surgical kits explained

Makers must assemble and pack sterile kits in a controlled environment, so that particles and microorganisms stay to a minimum before sterilisation. That environment is a clean room. Clean room manufacturing therefore protects every sterile kit before it is sealed. Clean room manufacturing therefore protects every sterile kit until sealing.

What a clean room is

A room with filtered air, controlled pressure and strict rules for people and materials. The ISO 14644 standard classifies clean rooms by how many particles the air may contain.

Clean room rules

• Staff wear gowns, hair covers and gloves
• Materials enter through airlocks
• Staff clean surfaces on a schedule
• Staff monitor air and surfaces

Why it matters

Fewer contaminants before sterilisation means a more reliable sterile product.

What to ask a manufacturer

• What class is the clean room?
• How do they monitor it, and how often?
• Can I see the monitoring records?

Questions to ask about clean room manufacturing

When you assess a supplier’s clean room manufacturing, ask simple, direct questions. First, which class is the clean room, and how often is it tested? Next, how are staff trained, and what do they wear inside? In addition, how are particles and microbes monitored? As a result, you will see whether the process is under control.

Also, ask to see records, not just certificates. A well-run clean room keeps logs of cleaning, testing and any deviations. However, a short video tour can help if you cannot visit in person.

The cleanroom overview explains the main classes and rules. To learn about our own clean room manufacturing, see our quality page.

Questions to ask about clean room manufacturing

When you assess a supplier’s clean room manufacturing, ask simple, direct questions. First, which class is the clean room, and how often does the maker test it? Next, how does the maker train staff, and what do they wear inside? In addition, how are particles and microbes monitored? As a result, you will see whether the process is under control.

Also, ask to see records, not just certificates. A well-run clean room keeps logs of cleaning, testing and any deviations. However, a short video tour can help if you cannot visit in person.

The cleanroom overview explains the main classes and rules. To learn about our own clean room manufacturing, see our quality page.

Tata Surgical’s clean room

We assemble and pack sterile kits in our clean room in Sialkot. Ask for a video tour.