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Environmental Monitoring

The purpose of Environmental Monitoring (EM) is to establish alert and action limits and continuously validate the integrity of the cleaning and disinfecting programs.  ACM helps develop Environmental Monitoring Programs according to ISO 14698-1&2.

EM Services

ACM offers Nationally Recognized Testing Laboratories (NRTL) for EM data management.

We offer daily, weekly and quarterly EM programs for areas such as:

  • Fill/Finish
  • Formulation
  • Tank Rooms
  • Laminar Flow Hoods
  • Biological Safety Cabinets
  • Isolators/Glove boxes
  • IV Compounding
  • Sterile Packaging
  • Medical Device
  • Cosmetic
  • Food
  • Vaccine
ACM Environmental Monitoring
EM Plates
ACM EM Technician Microscope
Plates Multi Colored
EM Technician

What does ACM Monitor?

High contact equipment such as tabletops, process equipment, walls and floors are monitored regularly to ensure that the cleaning program is consistent and compliant.

Personnel are monitored to assess the effectiveness of the gowning program. A qualified person uses contact plates to monitor areas of the gowned body that may interact with the sterile field or product exposure areas. These may include gloved hands, forearms, or other areas.

Air samples are measured in two ways; the first being by drawing in predetermined volumes of air over a sterile growth plate and the second exposing growth plates to the environment for a specific period of time.

A Hepa HVAC system can account for 99.97% of all of the non-viable and viable particulates throughout the controlled area, the remaining 0.03% will settle and contribute to Alert and Action levels.

Surfaces are monitored to measure the effectiveness of the cleaning program. High contact equipment such as tabletops, process equipment, walls and floors are monitored regularly to ensure that the cleaning program is consistent and comprehensive.

ACM will help your manufacturing facility develop a Environmental Monitoring Program as a proactive way to assure cleanliness is maintained.

Custom EM Program Features:

  • Establish static and dynamic monitoring times and locations
  • Use calibrated instruments and media within expirations
  • Sample air and surfaces for viable bio-burden
  • Sample water and steam lines
  • Incubate samples according to ISO 14648 or customer’s SOPs
  • Count, record gross morphology and as required, Gram stain
  • Perform species identification as requested.
  • Test air and nitrogen lines and send sampling canisters out for testing.
  • Perform trend analysis.  Trend analysis will be sorted by Gram staining, gross morphology, quantity and locations.  Species identification will be performed as required and included in the trending chart.
  • Input data into customer software.
  • Participate in, investigate excursions as requested or required.

For Effortless Compliance trust the Environmental Monitoring of your cleanroom to the experts in the business. For more information on EM testing procedures, see below.  You may also contact us and speak to one of our dedicated professionals for a consultation on how ACM can best service all your cleanroom needs.

PROCEDURES

To ensure the cleanliness and microbial control within a cleanroom environment, it’s crucial to follow aseptic techniques when conducting air and surface contact plate tests. Below is a detailed outline of the procedures for collecting and analyzing microbial samples:

1. Aseptic Technique

  • Use aseptic techniques throughout the sampling process to prevent contamination and ensure accurate results. This includes sanitizing equipment and handling samples carefully to avoid cross-contamination.

2. Surface Contact Plate Sampling

  • Take one contact plate sample at each designated location within the cleanroom.
  • Label and record each sample plate with relevant information (e.g., location, time, and date of sampling).
  • Incubation Conditions:
    • Incubate the contact plates at 30 – 35°C for a specified number of hours (typically 48-72 hours) to allow microbial growth.
    • Also incubate the plates at 22 ± 2°C for a specified number of hours, as per cleanroom standards or project specifications.

3. Air Sampling

  • Use an air sampler to collect air samples, following the same aseptic protocols.
  • The air sample results are enumerated using the following formula:
    • CFU/Liter = Colonies on Plate
    • Amount of Liters of Air

4. Counting and Reporting Data

  • Macroscopic Identification (Contact Plate Samples):
    • Count the total recoverable aerobic bioburden as CFUs (Colony Forming Units) per sample. This count is performed macroscopically by inspecting the plates.
  • Microscopic Identification (if applicable):
    • Microscopically identify and report any additional microbial presence as necessary.
  • If more than one sample is taken from the same location, average the CFUs and report the result in CFUs per plate for accuracy and consistency.

5. Reporting Data

  • All data collected from air and surface samples, including counts and CFU calculations, should be compiled and presented in the test report. This includes any relevant environmental conditions during sampling and incubation.

Instrumentation and Calibration

  • Air Sampler:
    • Calibration documents for the air sampler used in testing will be included in the certification report, ensuring accuracy in airflow measurement and sampling efficiency.
  • Contact Plates:
    • Quality control documents for the contact plates used in testing will be included in the certification report to verify the validity and reliability of the sampling materials.

Why Perform These Microbial Tests?

  • Regulatory Compliance:
    • Microbial testing is essential for ensuring cleanroom environments meet ISO, GMP, and FDA standards for microbial limits.
  • Product Safety:
    • Identifying microbial contamination in controlled environments prevents contamination of sensitive products and processes.
  • Operational Assurance:
    • These tests help maintain cleanroom integrity, providing ongoing validation of air and surface cleanliness.

Partner with ACM for Microbial Testing

ACM provides comprehensive microbial testing services, including air and surface contact plate sampling, to ensure your cleanroom environment remains compliant, safe, and contaminant-free. With certified technicians, reliable equipment, and detailed reporting, we help you maintain operational efficiency and regulatory compliance.

Contact ACM today to schedule your microbial testing and ensure your cleanroom operates at peak performance.

ACCEPTANCE

The acceptance criteria for microbial testing and environmental monitoring are established based on mutual agreement between the buyer and seller, and/or the limits set by the customer’s validation results. These criteria define the acceptable levels of contamination, ensuring that the cleanroom or controlled environment meets the specific requirements for operational performance and regulatory compliance.

ISO 14698

ISO 14698 provides the framework for establishing biocontamination control in cleanrooms and associated controlled environments. It outlines principles, methods, and procedures to assess and control biocontamination risks when cleanroom technology is applied for microbial control.

ISO 14698-1: General Principles and Methods

Part 1 of ISO 14698 sets forth the general principles and methodologies for a formal system of biocontamination control. The standard is aimed at assessing and managing biocontamination when applied to cleanroom technology for microbial control.

Key points:

  • Specifies the methods for monitoring risk zones in a consistent manner.
  • Control measures are implemented based on the degree of contamination risk in specific zones.
  • In areas with low contamination risk, this standard serves as an informational guide, offering valuable insights into environmental conditions.

ISO 14698-2: Microbial Cleanliness Levels

Part 2 of ISO 14698 provides guidance on evaluating microbiological data and assessing results obtained from sampling viable particles in designated risk zones. This standard complements ISO 14698-1, offering more detailed methods for microbial cleanliness evaluation.

Key points:

  • Focuses on the evaluation of microbiological data from risk zones to ensure biocontamination control.
  • Supports consistent decision-making by estimating results from sampling for viable particles.
  • Used in conjunction with ISO 14698-1 for comprehensive biocontamination management.

Why ISO 14698 Matters for Cleanroom Environments

  • Standardized Approach:
    • Provides a consistent method for assessing and managing biocontamination in cleanrooms and controlled environments.
  • Risk-Based Control:
    • Ensures that control measures are applied according to the level of contamination risk, improving operational efficiency and product safety.
  • Regulatory Compliance:
    • Helps facilities adhere to ISO, GMP, and other regulatory standards, ensuring proper microbial control in sensitive environments.

Partner with ACM for Biocontamination Control

ACM follows ISO 14698 standards to provide biocontamination control solutions that help maintain cleanroom integrity and regulatory compliance. From microbial cleanliness evaluations to risk zone management, we ensure your cleanroom meets the highest standards of cleanliness and safety.

Contact ACM today to learn more about our biocontamination control services and how we can support your cleanroom needs.