Bacteriostatic Water Quality Standards

What are bacteriostatic water quality standards?

Bacteriostatic water quality standards are defined by the United States Pharmacopeia (USP) in chapter <71> for sterility testing and other relevant chapters. These standards ensure the water is free from microbial contamination and suitable for use in laboratories and manufacturing processes. BAC Water Depot adheres to these standards in their manufacturing process. The standards include strict limits on microbial contamination, with no more than 10 CFU/mL for bacteria and no more than 5 CFU/100mL for fungi.

What is USP bacteriostatic water?

USP bacteriostatic water is water that meets the standards set by the United States Pharmacopeia (USP) for sterility, purity, and quality. It is tested for sterility according to USP <71> and is suitable for use in pharmaceutical applications, laboratory testing, and other applications where high-quality water is required. The USP standards for bacteriostatic water include a requirement for a bacteriostatic agent, such as benzyl alcohol, to be added to the water to prevent microbial growth.

What are GMP bacteriostatic water regulations?

GMP (Good Manufacturing Practice) regulations for bacteriostatic water require that the water be manufactured, tested, and packaged in a way that ensures its quality and purity. This includes requirements for the water's sterility, purity, and labeling, as well as for the manufacturing facility's cleanliness, sanitation, and quality control procedures. Bacteriostatic water manufactured according to GMP regulations is suitable for use in pharmaceutical applications and other industries where high-quality water is required.

What is the pricing for bacteriostatic water?

The pricing for bacteriostatic water varies depending on the quantity purchased. A single 10 mL vial can cost around $9.99, while a 10-pack can cost $74.99. Bulk pricing is also available, with 25 vials costing $7.49 per vial, 50 vials costing $6.99 per vial, and 150 vials or more costing $6.74 per vial. For very large quantities of 500 vials or more, the price per vial can be as low as $6.49.

How is bacteriostatic water tested for sterility?

Bacteriostatic water is tested for sterility according to USP <71> using a combination of methods, including membrane filtration and direct inoculation. The water is filtered through a sterile membrane filter, and the filter is then incubated in a nutrient medium to detect any microbial growth. Additionally, the water is directly inoculated into a nutrient medium to detect any microbial contamination. BAC Water Depot tests every lot of bacteriostatic water for sterility and provides a Certificate of Analysis for each lot.

What is the role of a Certificate of Analysis in bacteriostatic water quality control?

A Certificate of Analysis (COA) is a document that provides detailed information about the quality and purity of a batch of bacteriostatic water. It includes test results for sterility, purity, and other relevant parameters, and is typically provided by the manufacturer. The COA serves as proof that the water meets the required standards and is suitable for use in various applications. BAC Water Depot provides a COA for each lot of bacteriostatic water, which can be accessed online via a scannable QR code on the label.

What are the bacteriostatic water regulations for shipping and storage?

Bacteriostatic water regulations for shipping and storage require that the water be handled and stored in a way that maintains its quality and purity. This includes requirements for packaging, labeling, and transportation, as well as for storage conditions such as temperature and humidity. BAC Water Depot ships bacteriostatic water from a US fulfillment center on the same day the order is received, ensuring that the water is delivered to the customer in a timely and controlled manner, and the water is stored in a facility that meets ISO 9001:2015 standards.