18 Questions
What is the primary goal of bioburden control in aseptic processing?
To ensure safety of sterile products
What is a major challenge in clean room environments?
Human contamination potential
What is the purpose of a written procedure in sterile product manufacturing?
To comply with regulations
What is a key feature of Mactus SACS?
Biometric access system
Why is bioburden control crucial in sterile product manufacturing?
To prevent contamination and ensure product safety
What is the main source of risk in clean rooms?
Operating personnel
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
What type of alerts can be provided to ensure personnel adhere to qualified/validated times in the clean room?
Audio alerts/early warnings
What is the purpose of the Announcement system in the clean room?
To enable supervisors to provide one-way communication to the area
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
What is the purpose of implementing optional health checks in the clean room?
To provide additional safety measures for personnel
What regulatory requirement is met by this installation?
21 CFR Part 11/Annex 11
What is a key benefit of the Mactus SACS Solution in terms of compliance?
Meets global health authority expectations
What is a feature of the Mactus SACS Solution that reduces investigation time and resources?
Design features that minimize risk
What is a benefit of the Mactus SACS Solution in terms of operational efficiency?
Delivers right first-time results
What is a key feature of the Mactus SACS Solution in terms of data management?
Data generated in compliance to ALCOA+ expectations
What is a benefit of the Mactus SACS Solution in terms of cost savings?
Minimizes batch rejections
What is a unique feature of the Mactus SACS Solution?
Patent pending
This quiz is about the Smart Access Control System (SACS) by Mactus Automation, a configurable solution for managing compliance in clean room environments. It covers bio burden control, good manufacturing practices, and sterile product manufacturing.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
