Our Cutting-Edge Facility
PMRS is blazing a trail for the next generation of comprehensive pharmaceutical production services. Our 130,000 square foot facility was custom built to meet and exceed cGMP requirements. It houses the highest-caliber equipment, people, and safety systems that our industry has to offer.
Our facility boasts:
- 39 Manufacturing Suites:
- Covers 30,000 square foot
- Low humidity suites (30% RH)
- Light Sensitive Product Suite
- Equipment Chases
- Temperature and humidity controlled
- Ability to configure to individual product requirements
- A 16,000 square foot warehouse with 1,335 pallet positions
- 1040 general pallet positions
- Label cage storage (100 pallet position)
- 5°C storage (64 pallet positions)
- 2 Analytical Laboratories (11,000 square foot and 20,000 square foot)
- Raw Materials Laboratories
- Microbiological Laboratories
Facility Monitoring:
- Compressed air system: monthly viable and non-viable
- Environmental
- Monthly active air (bacterial and fungal)
- Monthly non-viable particulate air sampling
- Annual HVAC certification
- Purified Water System
- Day of Use (micro and chemical)
- Weekly: Make up and rotating basis
- AmegaView facility monitoring system
- Interior and exterior monitored security system
- A purified water, USP System (RO/EDI)
- 100% HEPA filtration
- Backup diesel generators and power UPS systems
- Nitrogen Generator
- Chemical and Biological safety hoods
- Access/Fire/Security systems
- Computer-based building monitoring system including alarming
- Bar-coded and RFID-enabled tracking system for materials and equipment
- Web-based incident management systems.
- Web-based document control system with unique client access to data, accessible 24 hours/ day
- Steam and hydraulic hot water boiler
- Clean, oil-less air compressor
- Separate chemical storage and containment buildings
- State-of-the-art energy efficient roofing system
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The Analytical Lab
While other companies have cut costs, PMRS has invested in the future. We have constructed a state-of-the-art, 11,000 square-foot analytical laboratory. Whether through dedicated contracts or individual quotes, this advanced facility will ensure continued production of superior pharmaceuticals.
The analytical lab boasts:
- Capacity for 50 HPLC’s and 30 dissolution baths
- Wireless temperature/humidity control and monitoring
- Power UPS Systems which provide continuous power until onsite generators are activated
- A 5°C walk-in refrigerator, -20°C storage, and solvent storage unit
- Isolated balance room with 4 weigh stations and a Class III glove box
- 34 lab benches, 5 lab hoods, and 8 point of use exhausts (snorkels)
- Two Miele lab glassware washers, 21 sinks, and 33 cup sinks on benches
- Hydrogen, helium, oxygen, clean air, compressed air, vacuum, domestic hot/cold
- Natural and recessed lighting
The analytical laboratory also implements our unique configuration of Labware LIMS. Processes will be set-up, controlled, tested, and reported using Labware LIMS. Training, SOP, and equipment requirements will be captured eliminating error. All data will be transferred and recorded electronically reducing administration time and increasing efficiency.
What This Means for You:
This world class, state-of-the-art analytical laboratory is not only an investment for our future, but our customers’ futures as well. This component of our custom facility provides our people with the flexibility to exceed all of our clients’ present and future needs. The analytical laboratory was designed by building quality in. This allows PMRS to eliminate risks to products, reduce costs to our clients, and excel in the production of the highest quality.
Purified Water System
A reliable and predictive water treatment process is imperative for the production of world class pharmaceuticals. PMRS makes use of the most advanced and efficient technologies to provide USP water 7 days a week, 24 hours a day, 365 days a year.
Online Water Bioburden Analyzer
PMRS has instituted an Online Water Bioburden Analyzer (OWBA) for our USP Water Loop which supplies all manufacturing processes at our facility. The OWBA provides continuous, real-time data for biologic particles in the USP water system 24 hours a day, 7 days per week. Online monitoring offers early indication of system excursions and comprehensively ensures that the water being used meets requirements prior to and throughout the entirety of its use.
The OWBA system is capable of detecting waterborne biologic particles (including bacteria, yeasts and molds) in real time. The OWBA detects the intrinsic or auto-fluorescence signal chiefly from Nicotinamide Adenine Dinucleotide (NADH) and Riboflavin, which are present in all cells, and Dipicolinic Acid (DPA), which is found in bacterial spores. The presence of a fluorescence signal serves as a strong indicator of microbial presence in the water sample being processed and is used to differentiate biologics from inert particles.
This instrument creates enormous opportunity to understand our water system in a way that was not possible before. Real-time biologic and inert particle counts paired with the existing PMRS monitoring of Online TOC and Conductivity, Temperature, Flow Speed, Flow Pressure, and Tank Level provides real time data, predictive analytics, overall risk reduction, and greater assurance to specifications.