Delivering health in small packets

Clinical Packaging

Through comprehensive packaging research, Bilcare GCS produces customized and innovative clinical packaging materials. Bilcare GCS assists its clients in selecting appropriate packaging solutions through complete production and delivery.

Our packaging services are carried out by experienced clinical packaging professionals at our dedicated GMP compliant clinical packaging facilities.

  • Bottling (solids / semi-solids)
  • Blister packaging – any configuration
  • Cold form & thermoform
  • Blister card sealing and walleting
  • Pouching / powder filling
  • Label application and kit assembly
  • Controlled substance packaging (schedule I – V)
  • Ambient & controlled temperature (refrigerated / frozen) packaging
  • Tube filling
  • Creams
  • Ointments
  • Label printing with vision system.(Single panel,Multipanel booklet labels)

Bilcare GCS' extensive clinical services experience and expertise actively supports and helps customers in the decision-making process to understand the long-term impact of packaging decisions.

  • Evaluation of packaging efficacy through physicochemical requirements and actual field performance
  • Packaging cost evaluation including indirect costs such as transportation and storage
  • Compliance with international regulations and guidelines
  • Quality control and quality assurance evaluations
  • Evaluation of packaging productivity based on process & machine efficiency, machine time utilization & production waste
  • Study of distribution impact
  • Design characteristics for functionality, compliance & end-use efficacy
  • Optimizing the packaging in terms of efficacy, cost & aesthetic appeal
  • Formulation evaluation in terms of environmental sensitivity & packaging needs

Bilcare OptimaTM

Packaging is a big concern for companies in pharmaceutical sector. According to ICH guidelines the optimal amount of humidity and temperature has to be maintained while packaging, so that the formulation retains its stability. Not knowing what the exact packaging requirement for their products is, the pharma manufacturers often end up either packaging their product above or below the desired requirement. Above requirement means they purposely pack their formulation in high barrier packaging materials. This is done to reduce analytical workload and qualifying for the stability tests. However, over-packaging may unnecessarily add up to the packaging cost.

Packaging below the desired requirements means that the manufacturer is focusing only upon the ICH guidelines. However, the ICH guidelines are formulated by considering the temperature and humidity conditions in Zone I & II (USA and European regions) only. These guidelines do not necessarily assure stability of a formulation in tropical regions. If a manufacturer decides to stick to ICH guidelines only, then it may lead to catastrophic losses for him in tropical regions. Bilcare has come up with a very innovative and cost-effective solution for this problem. Bilcare OptimaTM is a result of 11 years of incessant study and analysis of exact packaging requirements of a formulation.

This first and only scientific packaging development method understands the exact packaging requirement of the pharmaceutical formulations. This is done through a scientific study that quantifies the environmental and dimensional sensitivity of the pharmaceutical formulations. Thus, it identifies the optimum packaging of any pharmaceutical dosage by understanding the degradation pattern of the formulation and then correlating it to the barrier property of the packaging material without conducting the conventional stability studies. Bilcare then submits the report along with recommendations for primary blister packaging materials and a suitable back up packaging alternative for the product within 30 days time after initiating the study.

Bilcare OptimaTM works on the following principles:

  • Sensitive profiling of solid dosage formulations.
  • Scientific identification of optimum packaging.
  • Hygroscopicity: The ability of a substance to attract and hold water molecules from the surrounding environment.
  • Degradation : Retaining in physical or chemical properties.
  • Drug release properties (DT and Dissolution).
  • Mechanical properties (Hardness/Friability).
  • Photosensitivity as a function of RH & Temperature.
  • Gas liberation tendency.
  • Dimensional aspects (Film Thinning).
  • Determining barrier requirements of package through mathematical modeling. This includes
    • Moisture barrier
    • Light Barrier
    • Gas barrier
    • Dimensional requirements
  • Thinning profile through simulation software
  • Defining film structure
  • Reduce analytical resource loading
  • Shorten package development time
  • Start stability test without worry
  • End of over-packaging
  • Long-term saving on materials
  • Prevent under-packaging
  • Prevent after sales quality issues
  • Optimum packaging solutions
  • Cost Effective

Bilcare OptimaTM technology can be effectively implemented for:

  • New formulation
  • Bottles
  • Blisters
  • Alu-Alu
  • Alu strips
  • Double packs