Quality

Quality is the standard by which our equipment and procedures are measured. Our cutting-edge technology and impeccable standards ensure that our customers receive products that meet their exact needs.

Quality Systems

• All procedures adhere to cGMPs
• Training programs are in place and help enhance operators’ skills
• QA-controlled documentation (SOP/Specification/MBR)
• Change control system
• Non-conformity, complaints and deviations are reported in system and trended
• Quality documentation stored for six years in controlled archives

Quality Controls During Production

• Checkweighers and other control/inspection devices are utilized throughout the packaging process
• On-line inspection for all production performed by qualified personnel
• Dedicated quality assurance/quality control personnel ensure strict cGMP compliance to SOPs and FDA regulations
• Detailed batch record documentation accompanies every project
• Non-compliant products and components stored in controlled access quarantine area
• All instruments are calibrated

Accreditations

• Food and Drug Administration (FDA)
• Health Products and Food Branch (HPFB)
• Establishment License for pharmaceutical products:
  • Manufacturing, packaging/labelling, importing and wholesaling
• ISO 9001:2000
• cGMP and HACCP compliant
• Client audits: over 100 pharmaceutical customers in U.S., Canada and the E.U.
• Controlled substance license with level 9 vault security
• Licensed for Class A precursor products
• Licensed for natural health products
• Organic certification
• Approved facility for U.S. Military/NATICK and Canada DND

Confidence and Experience

Ropack offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages, tablets, powder, and encapsulation into blisters, pouches, bottles, and carded blisters.

• Our facilities are cGMP compliant and FDA certified


• Competitive, flexible and agile; supporting clinical trials, short-run start-ups, commercial production and warehousing and distribution services for over 90 U.S. Canadian and European pharmaceutical and nutraceutical customers


• A proven track record in new product launches to help support and accelerate go-to-market timelines


• Integrated project management, quality and operations functions allow Ropack to adjust our operations to fast-track new product launches


• New drug product launches are coordinated to coincide immediately post-FDA approval

Technology

No matter what you require, Ropack is equipped with the latest and best technology to make sure your needs are fulfilled. Our impeccable quality standards and unflagging dedication to perfection mean our facilities are second to none.

HVAC Ventilation and AC Systems

• Siemens controls
• HEPA terminal filters
  • Positive pressure
  • Air return located 18 in. above floor
  • Creation of laminar air flow
  • 99.997% air purity at 0.03 microns
  • 25 Class 100,000 individual production rooms
    • Temperature and relative humidity controls
    • Validated production equipment (IQ, OQ)
    • Product PQ adjusted upon client request
    • Ability to handle products with limited ambient packaging/labelling time frames

Compressed Air System

• Oil free
• Hydrocarbon free
• Dehumidification system (-40 °C dew point)
• Prevents air condensation within packaging
• Protects quality of products
  • Validated IQ, OQ, PQ
• Electronic inspection system
  • Vision system
  • Checkweighers and inspection devices are utilized throughout the packaging process
• Bottling lines (integrity and presence)
• Blister pack lines (integrity and presence)
• Cartoning lines (pharmacode and bar code inspection)

Centralized Supervision and Control of Building Facilities

• Environmental conditions monitored
• Alarm management

Customer Business Portal Web Site

• Real-time customer order information
• Customer contact information
• Shipping address
• Customer purchase order number
• Sales order document number
• Assigned manufacturing number
• Requested date & promised date
• Order description and status

Capacity

Hard work is just part of the Ropack ethos, and we prove it daily through our output: high-capacity turnover that does not compromise our quality or excellence. All estimates based on three six-hour shifts per day.

Blister Manufacturing Capacity: Regular Blisters using PVC, PVC/PVDC, PVC/PE/PVDC, Aclar Rx, Aclar VA7300, and Cold-Formed (using aluminum/aluminum)
500,000 blisters per day

Bottling Filling Capacity: HDPE or PET bottles with induction seals, permaseals, child-resistant or senior-friendly caps
150,000 bottles per day

Sachet Filling Capacity; Powder, Liquids and Tablets:
540,000 sachets per day

Capsule Filling Capacity:
1,000,000 capsules per day

Tableting Capacity:
500,000 per day

In-House Engineering

Innovation and excellence: two qualities that Ropack strives to always deliver, thanks in no small part to our in-house engineering team. We’re here to work with you to develop the exact solutions you need, when you need them.

Tool Design Engineering

• AutoCad^® 3-D designs & layout drawings
• Pro/ENGINEER^® 3-D – integrated 3D CAD/CAM/CAE solution

Machine Shop

• Conventional machining capabilities
• Tool fabrication
• Rapid turnaround for in-house custom tooling

Automation Projects

• PLC programming
• Machine rebuilding
• Automation design and integration