About us
Controlled Manufacturing. Documented Quality.
UltraBac Water is focused on controlled manufacturing, testing and packaging of bacteriostatic water for qualified professional and institutional customers.
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our facility
A Controlled Manufacturing Environment
Production activities are performed within controlled environments using documented procedures for personnel, equipment, materials and environmental conditions.
Facility
ISO 9001:2015 Certified Manufacturing Facility, Massachusetts
QUALITY SYSTEM
cGMP Compliant & USP Monograph Standards
CLEANROOM
ISO Class 7 (Class 10,000) Controlled Environment
PRODUCTION
50,000+ Units / Month Automated Liquid Filling Capacity
manufacturing process
Controlled every manufacturing stage
Every batch is manufactured under strict protocols and quality control, and supported by comprehensive documentation.
MATERIALS
Materials are identified and evaluated against approved requirements.
FORMULATION
Formulation is prepared under controlled conditions.
FILTRATION
Product passes through the specified filtration process under controlled conditions.
FILLING
Filled into sterile containers in a controlled environment.
TESTING
Finished product is evaluated against applicable specifications.
BATCH REVIEW
Production and testing records are reviewed before release.
RELEASE
Approved for distribution to qualified customers.
Quality Control
Quality Is Verified Before Release
Our quality control program includes identity testing, microbiological evaluation and physical/chemical analysis. All testing is performed according to approved product specifications and procedures.
Identity
Verification of applicable product and material attributes.
Microbiological Quality
Testing performed according to the approved product specification and procedures.
Physical & Chemical Testing
Product characteristics are evaluated against defined acceptance criteria.