LAB 797 is introducing Water Testing: USP 1231 & ANSI/AAMI ST108

When it comes to your pharmacy or facility, water isn’t just water. It’s a critical ingredient and utility that directly impacts the quality and safety of your products. That’s where USP 1231 and ANSI/AAMI ST108 come into play. Both standards provide guidance on how water is tested to maintain microbiological quality.

Why is USP 1231 Important?

Water is used widely for many pharmaceutical purposes, such as cleaning, formulation, or as finished product components. USP 1231 discusses how water systems are designed and maintained to prevent microbial contamination, how to monitor and control microbial growth, and relationships between water quality and drug product safety.  There are two types of pharmaceutical water – purified water and water for injection. Purified water is used for non-parenteral formulations and cleaning. Water for injection is used for parenteral formulations, therefore meeting stricter quality standards.

Why is ANSI/AAMI ST108 Important?

ST108 discusses water for the processing of medical devices, setting a standard for water quality used in cleaning, rinsing, disinfection, and sterilization. This is a relatively new standard that regulatory bodies will begin to expect healthcare facilities to demonstrate. ST108 defines four categories of water quality (utility, critical, steam, and final rise). By compliance with this standard, facilities can protect patients’ safety, reduce risks of device damage, and improve internal infection control programs.

Do I choose USP 123 or ANSI/AAMI ST108?

This depends on what industry your facility is in.

Choose USP 1231 if:

• You are in the pharmaceutical or biotech industry

• You use water in manufacturing, formulation, cleaning, or testing of drugs

• You are designing, validating, or maintaining a pharmaceutical water system

Choose ANSI/AAMI ST108 if:

• You are in healthcare, sterile processing, or medical device testing

• You use water to clean, rinse, disinfect, or sterilize reusable devices

• You use sterile processing in hospitals, surgical centers, or clinics

How can LAB 797 help?

Using heterotrophic plate count methods, we can determine the amount of CFUs (colony-forming units) of bacteria present in a water sample. This allows us to help your pharmacy or facility establish a routine to monitor the bioburden in your water. Contact us for a special introductory rate today!

Mass Spectrometry for Identification- How does it work?

MALDI-TOF (Matrix Assisted Laser Desorption Ionization) is used as a method of rapid microbial identification. LAB 797 utilizes this technology at our facility, allowing us to provide you fast and accurate results.

Samples are prepared for analysis by being coated with an energy-absobent matrix solution. The solution crystalizes upon drying, encasing proteins within it. The matrix is then ionized with a laser beam, the ions are charged, and they are accelerated within the MALDI-TOF device. Ions are seperated based on a mass-to-charge ratio (m/z) and visualized against a known spectra of organisms within a microbial library. Once identified, the system will output an identification for the organism.

The entire process, including preperation time, can deliver a microbial ID, start to finish, in approximately 5-10 minutes.

Other applications for MALDI-TOF include specialty imaging, polymer analysis, quality control, cell research, and proteomics.

Let us work with your facility to ID any of your bacterial or fungal isolates. We have an ID-Only program where you can send us growth from your facility, we work to ID the organisms, and get you results within 72 hours. Contact us to learn more.

Developing a Sampling Program for Monthly Environmental Monitoring

Today, many facilities are conducting internal surface sampling of their cleanrooms in addition to their biannual cleanroom certification. To remain compliant, pharmacies must develop a robust environmental monitoring plan that ensures sterility and cleanliness of their compounding areas as well as proper documentation of SOPs and results. Below are some tips on how to develop your sampling program. 

1. Identify Sampling Locations: Target any critical areas such as ISO 5 PECs, ISO 7 Buffer or Chemo Areas, and ISO 8 Ante Rooms. Sample high-touch or high-traffic areas. Sample near any sterile compounding activities.

2. Determine Sampling Frequency: Surface sampling is required by USP <797> at regular intervals but monthly is highly recommended. Air sampling is performed every 6 months by a certification company, like Medical Technology Associates.

3. Selecting Appropriate Methods: Use contact plates for surface sampling. Tryptic Soy Agar promotes the growth of bacteria, while Sabouraud Dextrose Agar promotes the growth of mold. Contact Plates can be purchased here. Follow incubation guidelines within <USP 797>.

4. Establish Action Levels and Responses: Set microbial levels based on ISO classifications. Develop a procedure for documenting, investigating, and addressing results beyond acceptable limits. It is recommended that any growth is sent to a third party, like LAB 797, for identification. Identification helps with determining the source of error and developing an action plan.

5. Document and Review: Keep records of sampling results and corrective actions. Look for trends in sampling. Regularly review your plan to adapt to any changes within your facility.

With a thorough sampling program, facilities can continue to ensure compliance. Reach out to LAB 797 if you have questions on developing a program. We are happy to help!