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Smart Access Control System (SACS) for Clean Room Environments

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Questions and Answers

What is the primary goal of bioburden control in aseptic processing?

To minimize equipment contamination
To ensure safety of sterile products (correct)
To increase product quality
To reduce production costs

What is a major challenge in clean room environments?

Raw material shortages
Human contamination potential (correct)
Equipment failure
Production delays

What is the purpose of a written procedure in sterile product manufacturing?

To minimize bioburden contamination
To comply with regulations (correct)
To reduce production time
To improve product quality

What is a key feature of Mactus SACS?

Biometric access system (D) Signup and view all the answers

Why is bioburden control crucial in sterile product manufacturing?

To prevent contamination and ensure product safety (C) Signup and view all the answers

What is the main source of risk in clean rooms?

Operating personnel (D) Signup and view all the answers

What is the primary purpose of controlling the number of personnel entering/exiting Clean Rooms?

To limit access to a permitted number and identify the purpose of each entry (A) Signup and view all the answers

What type of alerts can be provided to ensure personnel adhere to qualified/validated times in the clean room?

Audio alerts/early warnings (C) Signup and view all the answers

What is the purpose of the Announcement system in the clean room?

To enable supervisors to provide one-way communication to the area (D) Signup and view all the answers

What is the benefit of tracking user events in multiple filling lines with a common change room and sterile corridor?

To analyze and report on user events and improve efficiency (B) Signup and view all the answers

What is the purpose of implementing optional health checks in the clean room?

To provide additional safety measures for personnel (C) Signup and view all the answers

What regulatory requirement is met by this installation?

21 CFR Part 11/Annex 11 (C) Signup and view all the answers

What is a key benefit of the Mactus SACS Solution in terms of compliance?

Meets global health authority expectations (D) Signup and view all the answers

What is a feature of the Mactus SACS Solution that reduces investigation time and resources?

Design features that minimize risk (A) Signup and view all the answers

What is a benefit of the Mactus SACS Solution in terms of operational efficiency?

Delivers right first-time results (D) Signup and view all the answers

What is a key feature of the Mactus SACS Solution in terms of data management?

Data generated in compliance to ALCOA+ expectations (B) Signup and view all the answers