Sterile Products

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What is the ideal percentage range of solids in the frozen plug?

5-10%
10-15%
2-25% (correct)
30-35%

Which type of salts are recommended for providing uniform crystal size, color, and texture in sterile products?

Sulfates
Monobasic and dibasic sodium phosphates (correct)
Bicarbonates
Chlorides

What issue is commonly observed when using sodium chloride alone in sterile products?

Uniform crystal formation
Crusty and crumbly appearance (correct)
Increased dissolution rate
Volume expansion

What is the main purpose of long-acting parenteral drug formulations?

Simulate continuous i.v. infusion (A) Signup and view all the answers

Which approach is commonly used to control the rate of drug absorption in dissolution-controlled depot formulations?

Formation of drug salts with low solubility (D) Signup and view all the answers

How does particle size contribute to slow dissolution in long-acting formulations?

Large crystals dissolve more slowly (C) Signup and view all the answers

Why are stabilizers, such as antioxidants, added to certain preparations?

To stabilize the pH of the product (C) Signup and view all the answers

Which of the following is true about ophthalmic solutions used in larger quantities?

They are similar to large-volume parenteral solutions (A) Signup and view all the answers

Why are freeze-dried products typically aqueous?

For sublimation during the drying process (C) Signup and view all the answers

What is a crucial consideration for formulations of freeze-dried products?

Characteristics of the solid residue after drying (D) Signup and view all the answers

Why might substances need to be added to certain freeze-dried products?

To provide desired characteristics to the solid residue (B) Signup and view all the answers

Which characteristic is not a critical concern for ophthalmic solutions?

Absence of pyrogens (C) Signup and view all the answers

What is the typical range for the solids content of parenteral suspensions?

0.5 - 5% (B) Signup and view all the answers

Why is the property of thixotropy sometimes utilized in oleaginous suspensions?

To improve syringeability (B) Signup and view all the answers

What is the main challenge in formulating parenteral emulsions?

Achieving uniform oil droplets (D) Signup and view all the answers

Why is it important for parenteral emulsions to have uniform oil droplets?

For improved stability during storage (A) Signup and view all the answers

What factor determines the viscosity of parenteral suspensions?

Nature of the vehicle and amount of solids (A) Signup and view all the answers

Which product has been stabilized with lecithin as mentioned in the text?

A natural vitamin K1 emulsion (D) Signup and view all the answers

What type of glass provides the greatest chemical resistance according to the text?

Type I glass (D) Signup and view all the answers

Which test is performed on ground, sized glass particles according to the text?

Powdered Glass test (A) Signup and view all the answers

What type of glass is classified as providing the least chemical resistance?

NP glass (A) Signup and view all the answers

What is the purpose of using amber glass according to the text?

To filter out ultraviolet rays (B) Signup and view all the answers

Why are single-dose containers designed to be opened only once according to the text?

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

When might Types II and III glass be preferred over Type I for a product?

When the product contains a non-aqueous vehicle (B) Signup and view all the answers

What is the purpose of process control in the manufacture of sterile products?

To make various tests, readings, and observations throughout the manufacturing process (C) Signup and view all the answers

Why is it necessary to perform microbial load tests on incoming stock for sterile products?

To determine the number and types of microorganisms present (A) Signup and view all the answers

What is a key component of production control for sterile products?

Performing sterility tests (C) Signup and view all the answers

In the context of sterile products, what role does quality control play in the manufacturing process?

It encompasses tests on incoming stock, manufacturing, and finished products (A) Signup and view all the answers

What distinguishes process control from production control in the manufacture of sterile products?

Production control includes observing manufacturing process throughout (B) Signup and view all the answers

Why are leak tests, clarity tests, and sterility tests specifically mentioned as part of sterile product manufacturing?

To verify product quality and safety standards (A) Signup and view all the answers

What is the primary purpose of conducting microbial load tests on incoming stock for sterile products?

To assess the number and types of microorganisms present (C) Signup and view all the answers

Why is it crucial to perform a sterility test for sterile products?

To confirm the absence of viable microorganisms (C) Signup and view all the answers

What does process control involve in the manufacture of sterile products?

Making observations and measurements throughout the manufacturing process (A) Signup and view all the answers

In the context of sterile products, why might a clarity test be necessary?

To assess the visual appearance of the product (D) Signup and view all the answers

Which testing method is specifically mentioned as part of incoming stock control for sterile products?

Performing a microbial load test (A) Signup and view all the answers

What role does production control play in the manufacture of sterile products?

Performing final assays and tests on the product (D) Signup and view all the answers

Why are leak tests significant in the manufacturing of sterile products?

To ensure container integrity and prevent contamination (D) Signup and view all the answers