Right Answer: 1. Use sharper cutting tools.
2. Optimize cutting speed and feed rate.
3. Select appropriate cutting fluid or coolant.
4. Use a suitable tool geometry.
5. Reduce tool wear through proper maintenance.
6. Implement vibration control techniques.
7. Minimize cutting depth when possible.
Right Answer: Cutting clearance is the space or gap between the cutting tool and the workpiece that allows for the removal of material without causing damage to the tool or the part being machined.
Right Answer: Drill breakage can occur due to excessive feed rate, improper cutting speed, dull or damaged drill bits, inadequate cooling or lubrication, and incorrect drill alignment or setup.
Right Answer: The test that should be performed to detect leakage and penetration of steam in a steam sterilizer/autoclave is the "Vacuum Leak Test" or "Bowie-Dick Test."
Right Answer: Yes, GMP (Good Manufacturing Practices) is necessary even if there is a quality control laboratory, as it ensures that products are consistently produced and controlled according to quality standards throughout the manufacturing process.
Right Answer: The recommended bioburden limits for purified water (PW) is typically ≤ 100 CFU/mL, and for water for injection (WFI), it is ≤ 10 CFU/100 mL.
Right Answer: GMP stands for Good Manufacturing Practices, which are guidelines that ensure products are consistently produced and controlled according to quality standards.
Right Answer: Class B clean room garments are typically made from materials such as polyester, polypropylene, or a combination of these with additional treatments for static control and contamination prevention.
Right Answer: Yes, Good Manufacturing Practices (GMP) help boost pharmaceutical export opportunities by ensuring product quality, safety, and compliance with international regulations, which builds trust with foreign markets.
Right Answer: Viable limits for classified areas typically include zones where the risk of explosion or fire is present, such as Class I, Division 1 or 2 for flammable gases and Class II, Division 1 or 2 for combustible dusts. Non-viable limits are areas outside these zones where hazardous materials are not expected to be present in sufficient quantities to pose a risk.
Right Answer: CAPA stands for Corrective and Preventive Action. It is a process used in quality management to identify, investigate, and resolve issues to prevent their recurrence and to improve processes.
