Pharmaceutical devices

Passive safety system
Reconstitution system
Closure systems

For 20 years, BIOCORP has been a proven expert in the design and manufacture pharmaceutical devices. Our portfolio of proprietary products is composed of safety systems, reconstitution systems and closure systems.

Continuing to bring innovative solutions for our customers, our design and development team are committed to provide you with the expertise needed to initiate new product development program

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01

Newguard

Passive Safety System

NEWGUARD is a new generation of integrated passive safety device compatible with various sizes of stacked needles PFS. This innovation solution generates new benefits for pharmaceutical companies in terms of supply chain, TCO and packaging. Newguard meets both the economic criteria and the end users protection requirements.

Issues / Challenges Solution

Prefilled Syringes (PFS) is a fast growing market

  • Market is expected to grow from 4 billion units sold to 6,7 billions by 2020
  • Key drivers: vaccines & antithrombotic organic growth, launch of new injectable drugs, conversion from vials to PFS

Increasing pressure from regulators to add specific safety system to PFS

  • Directive 2010/32/EU & Guidance for industry and FDA Staff regarding Medical Devices with Sharps Injury Prevention Features of May 2015 require implementation of risk management plans to prevent injuries and contaminations
  • Explicitly mention safety system to rigid needle shield (RNS) as a key measure to reduce risks

Maximize safety for end users with no impact on industrial and regulatory processes

  • Optimal safety and comfort for end users before and after injection (formative evaluation conducted with nurses)
  • Minimize the change control and fulfill existing regulatory: use standard glass barrel and validated rubber formulation
  • Supply chain remains unchanged: use of regular validated Nest & Tubs from the glass supplier, then sterilization and filling process remain the same

NEWGUARD, a game changing safety system

  • Open source solution for pharma companies: compatible with all Glass & Elastomer suppliers
  • Standardization for 0,5 ml & 1 ml PFS
  • Product available for 1 ml short & 2,25 ml version
  • TCO reduction and secondary packaging optimization (size and costs)
  • Available in Thermoplastic Elastomer and most common rubber formulation
  • High acceptance by end users
  • Easy integration to existing processes (filling and packaging lines)
Safety
02

Biopass

Reconstitution system

BIOPASS ensures a smooth preparation of injectable medications. The BIOPASS system allows to reconstitute lyophilized drugs in a very convenient way. This user-friendly reconstitution system supports patients and caregivers for self-administration

Issues / Challenges Solution

Growing demand for reconstitution systems

  • Poor stability of therapeutic proteins
  • Increase of self-administration
  • Fastest time-market option

Challenges of the reconstitution system

  • Lack of expertise: complex process for patients & caregivers
  • Added risks: needle injuries (or improper dose)
  • Compliance concern: due to a complicated process

BIOPASS, an innovative reconstitution system

  • Compact system: embeds a needle ready for injections
  • User-friendly: easy to use even for non trained users
  • Time saving: 3 steps less than conventional reconstitution
  • Safe usage: less needle sticks manipulations
  • Repeatable process: reduced and constant residual volume
  • Customizable: can be adapted to specific needs

BIOPASS, an innovative reconstitution system

  • Easy fixation to 13 mm & 20 mm vials
  • Fits luer-lock syringes
  • Diluent transfer
  • Needle ready to inject

 

Reconstitution
03

Newseal

« Flip-Off » system

Compatible with standard vials

Easy-off

« Tear-Off » system

Compatible with standard vials

Carpseal

« Lineseal » system

Compatible with standard cartridges

Substitute aluminum with plastic could be a solution to tackle several industrial issues

  • Aluminum crimping generates aluminum & varnish dirts, which leads to contamination and transfer of fine particles on the primary container
  • Aluminum crimping is currently processed in non sterile environment, with risks of contamination for the final product
  • The handling of aluminum creates risks of injuries for healthcare professionals.

Contribute to:

  • Limit risks of contamination due to crimping operation
  • Guarantee product sterility : vial /cartridge sealed in sterile area
  • Improve user security : reduce risks of accidental injuries
  • Ease industrial process : sealing system by simple “snap-on” pressure
Closure