Controlled Environment and Utilities Monitoring

Cleanrooms and controlled environments are utilized to control the levels of non-viable and viable particulates that medical devices and pharmaceutical products are exposed to during the manufacturing process. The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation or other personnel/equipment issues. Keystone Labs can provide you with the appropriate level of service that you need to ensure your manufacturing environment complies with regulatory requirements, including:

  • Total Particulate Monitoring
  • Viable Particulate Monitoring (surface and air)
  • Full monograph testing of pharmaceutical waters (USP/EP/JP)
  • Sampling Plan Establishment

Keystone Labs has experience performing cleaning validations for your controlled environment. We can prepare validation protocols and final reports to establish sampling plans with appropriate sample sites and determine appropriate alert or action levels for your controlled environment rooms, clean steam and water systems.

Keystone Labs tests process water samples to monitor compliance with Pharmacopeial specifications, including:

  • Total Organic Carbon
  • Conductivity
  • Heavy Metals
  • Nitrates
  • Bacterial Endotoxin