Our lyophilization experts include engineers, scientists, skilled technicians and mechanics supported by a world-class quality organization. Because each project is unique, we draw on their expertise and experience as well as our wide range of services to develop and operate an optimum process for your product.
Our cGMP compliant facilities provide the flexibility to handle an ever-expanding assortment of processing challenges that involve formulation, lyophilization, packaging, process development / scale-up, and quality / regulatory consulting. We offer multiple, fully validated lyophilizers with capacities from 1 to 2,000 liters, and ISO 7 (class 10,000) clean suites.
Our staff are experienced in every facet of the lyophilization and formulation process. From the design of the process to the daily maintenance of the equipment, our capabilities meet the needs of the pharmaceutical, biotechnology, Medical Device and Nutritional Ingredient industries experience, and include:
- Technical and Business Management.
- Facility and equipment engineering, design and project management.
- GMP compliant manufacturing processes and regulatory requirements.
- Product and process compliance
- FDA submissions
- New drug and device applications
- FDA inspection liaison
- Quality systems
- Analytical methods
- Environmental control
- Validation consulting and implementation
- Microbiological / environmental testing and consulting
- Tablet and capsule manufacture
- Lyophilization equipment and design
- Milling, blending and granulating
- Protein purification
- Automated filling/packaging
- Storage, shipping and distribution services.
- First Class Customer Service
Equipment and Facilities
Our cGMP compliant equipment and facilities can be utilized for the most demanding lyophilization, formulation and packaging processes. Our capacities are unmatched, our equipment the best in the business.
- Capacities from 1 - 2,000 liters
- Stainless steel construction
- Internal stoppering
- Capacity to backfill with Argon or Nitrogen
- Sterilize in place (SIP)
Control and monitoring instrumentation.
Self-contained clean suites
- ISO 7 (Class 10,000)
- Dedicated HVAC with temperature and humidity control.
- Non-reactive, cleanable surfaces.
- Dedicated gowning / de-gowning areas.
Packaging and labeling
- Customized to meet the unique, industry-specific configurations of your product.
- Medical device packaging and labeling.
- Multiple configurations of bulk packaging for food and pharmaceutical ingredients.
- Milligram to ton capacities.
- Dedicated and custom-designed packaging operations.
- Multiple sizes and configurations of tank sizes and sanitary pumps.
- Agitation and temperature controls.
- USP purified water system.
- Controlled chemical storage and dispensing.
Shipping and handling
- cGMP compliant facilities for shipping and receiving grams to tons.
Complete documentation and traceability
- For all materials and products from purchase order through shipping with proximity to major transportation hubs and interstate highways.
- Equipment for unique processes, with the flexibility to expand if necessary.
- Vial filling, lyophilization and stoppering. (medical device and non-cGMP).
- Temperature and humidity-controlled storage (ambient to -40C).
Compliance and Quality System
Every project is carefully assessed for budget, timelines, and overall business objectives. We align your expectations with the highest quality standards, including technical excellence, innovation and service. Our quality system carries internationally recognized ISO 13485 2016 certifications.
ATTWILL meets the regulatory standards in each of the sectors we operate. Our Compliance and Quality staff constantly monitor the requirements and refine our facilities and systems to ensure we are compliant to all new developments. Our compliance and regulatory standards include: