Company Profile | July 16, 2008

Ropack - Contract Manufacturing And Packaging Services


 

Clinical Trial Management

Ropack, a rising leader in Canada for clinical trial management, focuses on getting drugs to market quickly, securely and cost-effectively. Services include packaging, expiration date relabeling, distribution, tracking, collection and certified destruction or storage of materials. Our qualified, responsive staff works in teams, providing insightful analysis and expert implementation to ensure a cohesive process that is efficient, reliable, secure, accurate and traceable. Our FDA and Health Canada-inspected facility offers ample storage, refrigeration, controlled substance storage vaults, comprehensive cold chain management as well as individual and segregated order-fulfilling and verification stations.

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Brochure: in-Canada Clinical Trial Distribution

Contract Manufacturing And Packaging Services

Ropack provides contract manufacturing and primary and secondary packaging of solid oral dosage, in-Canada clinical trial distribution, warehousing and North American and international distribution. Our portfolio of services support the vision of our customers – more than 90 leading pharmaceutical and consumer health-care organizations in the US, Canada and Europe – by providing 100 percent customer satisfaction, reducing product launch timelines and accelerating custom packaging requirements from clinical trial through scale-up and commercial launch.

Pharmaceutical blister, sachet/pouch, bottle and stick-pack packaging
Ropack's primary packaging services include blister and stick-pack packaging, sachet/pouch filling and bottle packaging of tablets, capsules and powders.  Our pharmaceutical manufacturing and packaging facilities, representing nearly 250,000ft², are cGMP-compliant, site-licensed by the FDA and Health Canada-certified and we hold a Natural Health Product license. Ropack recently invested nearly $9m to convert 15,000ft² for stick-pack packaging of temperature- and humidity-sensitive products.  We offer ample capacity, with 32 class 100000 modular Clean Rooms and bring operational and logistical efficiencies by running products on custom lines designed for shorter runs and quick changeovers, particularly efficient for the smaller Canadian market volumes.

Pharmaceutical formulation development
If you're bringing a product to market or have a new idea or approach, Ropack is an ideal partner in pharmaceutical formulation development. Our experience, expertise and state-of-the-industry facilities help bring your idea to life. Our pharmaceutical formulation development services include proof of concept; API characterization; pre-formulation; formulation and process development; analytical method development; and Phase I and II clinical trial material manufacturing and packaging.

Pharmaceutical contract manufacturing services
Our pharmaceutical and consumer health manufacturing services are carried out in fully licensed facilities and our capabilities meet the exacting requirements of our customers. Manufacturing services include encapsulation or double encapsulation, clinical trial manufacturing and packaging (CTM and vial labeling under brief excursion time, as well as packaging of temperature- and humidity-sensitive materials at 20% RH.

Primary pharmaceutical and consumer health packaging
Ropack's primary pharmaceutical packaging methods bring quality, reliability and efficiency.Primary contract packaging options include stick-pack packaging (general market as well as for pediatric and geriatric formulations) in a low RH, temperature-controlled environment; cold-form and thermo-sealed blister packaging with senior-friendly and child-resistant options; pouch filling of powders, solid oral dosage and liquids, including pouch filling under nitrogen and pouch filling within controlled-humidity environment; and bottling of powder and solid dosages.

Secondary pharmaceutical packaging
Secondary pharmaceutical packaging is a vital part of the preparation process. Ropack's secondary pharmaceutical packaging services prepare your products  for market safely and on time. We establish specifications and procurement of printed packaging materials and fulfill a range of secondary packaging requirements.  We insert bottles, blisters, stick-packs, pouches and leaflets into cartons and inspect barcodes and pharmacodes using scanning and vision systems.  Blisters are packaged in thermo-sealed cards and are also available in wallet format. We also provide labeling.

Pharmaceutical product warehousing and distribution
Ropack provides warehousing and distribution services for commercial products and clinical trial materials to locations in the US, Canada and Europe. From secure, stable storage to reliable shipment and delivery services, we can provide invaluable help in managing your products. We handle the reception of finished products and issuing of reception reports, as well as clinical trial distribution management, clinical trial return management, and management or destruction of returned materials from clinical trials.

Our warehouse has both ambient and cold storage capabilities (2°C to 8°C), and the minimum / maximum temperatures of the warehouse and refrigeration unit are documented. We have two vaults for controlled substances (level 9 security) with biometric access daily, weekly, monthly or annual inventory reports available.

We invite your next packaging challenge and invite you to use the form below to send us your business inquiry.

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Ropack Company Brochure: Contract Packaging Services
Video: Ropack – Facility and Capabilities Overview

Bottling: A validated system for exact filling of HDPE, PET & glass bottles with solid oral dose products. Child-resistant or senior-friendly caps.
Blister: Multiple formats including regular thermo-form, cold-formed & heat-resistant. Cards for promotional sampling, commercial distribution & clinical trials.  Single & folding wallet cards.
Stick-Pack: Production in low RH, temperature-controlled environment. Initial R&D, stability programs, sales & marketing samples, scale-up & commercial production.
Pouch/Sachet: Filling services for powder, solid, liquid & other dosage types.  Pouch/sachet filling under nitrogen; pouch filling available in a controlled-humidity environment. 
Clinical Trial Management: Ropack, a rising leader in Canada for clinical trial management, focuses on getting drugs to market quickly, securely and cost-effectively.

Encapsulation: Operating on three encapsulation machines, Ropack has a total encapsulation capacity of 300 MM.