Types of containers used for clinical packaging

Ampoule 

A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only. 

Bag 

A container consisting of surfaces, whether or not with a flat bottom, made of flexible material, closed at the bottom and at the sides by sealing; the top may be closed by fusion of the material, depending on the intended use. 

Blister 

A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded. bottle A container with a more or less pronounced neck and usually a flat bottom. 

Cartridge 

A container, usually cylindrical, suitable for liquid or solid pharmaceutical dosage forms; generally for use in a specially designed apparatus (e.g. a prefilled syringe). 

Gas cylinder 

A container, usually cylindrical, suitable for compressed, liquefied or dissolved gas, fitted with a device to regulate the spontaneous outflow of gas at atmospheric pressure and room temperature. 

Injection needle 

A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms. 

Injection syringe 

A cylindrical device with a cannula-like nozzle, with or without a fixed needle and a movable piston, used for the administration, usually parenteral, of an accurately measured quantity of a liquid pharmaceutical form. The syringe may be prefilled, and can be for single-dose or multi-dose use. 

Pressurized container 

A container suitable for compressed, liquefied or dissolved gas fitted with a device that, after its actuation, produces a controlled spontaneous release of the contents at atmospheric pressure and room temperature. 

Single-dose container 

A container for single doses of solid, semi-solid or liquid preparations. 

Strip 

A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations. Blisters are excluded. 

Tube 

A container for multi-dose semi-solid pharmaceutical forms consisting of collapsible material; the contents are released via a nozzle by squeezing the package. 

Vial 

A small container for parenteral medicinal products, with a stopper and overseal; the contents are removed after piercing the stopper. Both single-dose and multi-dose types exist.

Clinical Packaging and Labeling at Bilcare Research

Bilcare has emerged as a best and well known pioneer company in terms of Clinical packaging and labeling. Bilcare GCS has proven to be an able ally in delivering end-to-end services for your global clinical supply needs.

With a world class facility and classified suits of ISO 7 and ISO 8 equipped with sensors to monitor temperature and humidity with appropriate pressure differential, dedicated AHU'S to facilitate different products packaging at the same time, the AHU system being controlled by Building Management System.

To maintain the confidentiality, the entry is restricted by means of access control majors.

Walk in cold rooms for packaging of cold chain IP'S with backup of UPS and three generators .These walking Cold rooms are equipped with Eurotherm's 21 CFR compliant data loggers with audio video alarms for temperature excursions. Apart from this, it has also got the facility of mobile and email alerts.

The packaging activity is controlled by a approved batch clinical packaging document which in turn is managed by SAP system to have a better control on inventory and expiration dates.

Persons working in the operations areas are minimum graduate.

The entire facility is equipped with smoke detectors, fire extinguishers and fire hydrants. Dedicated specially designed document archival.

Our unique approach enables us to support customer requirements for short-term studies as well as large-volume ongoing projects. This is irrespective of whether the requirement is from Phase I studies, that requires limited supplies or Phase III, requiring an almost bulk approach to packaging.

Strategies of Clinical Packaging and an unexplored industry in India

With the advancement of science and technology, we see new medicines and pharmaceutical products being offered by a number of companies & trustworthy organizations and the packaging of medicine is one of the key factors which are as important as the health of people consuming it. Humidity of environment where these drugs are being packed, retaining its stability, recycling regulations, minimization of wastage and other similar factors are considered while packing the medicines and drugs.

The new and on-going trends in clinical packaging are safe and reliable, and they are crucially designed by keeping the potential and sensitive drugs in mind. The trends are:

    
> Child-resistant and senior-friendly packaging: the drugs are packed in a way which is easier for senior citizens to deal with and consume; and equally complex for children to avoid its misuse.

        
> Contract packagers’ automation: Clinical packaging processes have become more complex with the implementation of serialization and introduction of stringent anti counterfeiting guidelines. Pharma companies are increasing automating packaging lines as a result of same.

         
> Eco-friendly packaging: number of drug manufacturers and clinical packaging companies are considering environmental issues while packing their product as environmental concerns are valid too.

>  Anti counterfeiting packaging: DGFT of India has made it mandatory to use bar codes and unique numbers on primary-secondary packaging, along with territory packaging which is easy for tracking and tracing serialization of exported drugs.

> Talking packaging: is an impressive method of attracting consumers as it is a digital kind of packaging which includes HD screen on the outer packaging of the consignment, but it involves huge maintenance and distribution cost and that is why it is not trending in India along with the newness of this idea and risk factors associated with it.

Progress of this industry is innovation driven which is need of this hour and it will keep on coming with fresh ideas for clinical packaging time to time.

OPTIMUM CLINICAL PACKAGING AT BILCARE

Clinical packaging is a big concern for pharmaceutical companies in today's time. 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 Optima 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 Optima works on the following principles:

# Sensitive profiling of solid dosage formulations.

# Scientific identification of optimum packaging.

Clinical Packaging: an innovation driven industry and its Strategies

Don’t judge a book by its cover but definitely judge a medicine and drug by its packaging, because better the quality, better the function of service which is promised. With the advancement of science and technology, we see new medicines and pharmaceutical products being offered by a number of companies & trustworthy organizations and the packaging of medicine is one of the key factors which are as important as the health of people consuming it.

There are lot of factors considered while doing the clinicalpackaging of medicines and drugs, like humidity of environment where they are being packed, retaining its stability, recycling regulations, minimization of wastage, etc. Clinical labeling not only provide the essential information to its user, but it also assures that the medicine-drug belong to the company which uses clinical trial material and clinical trial services for quality maintenance of its products.

The new and on-going trends in clinical packaging are safe and reliable, and they are crucially designed by keeping the potential and sensitive drugs in mind. The trends are:

• Child-resistant and senior-friendly packaging: the drugs are packed in a way which is easier for senior citizens to deal with and consume; and equally complex for children to avoid its misuse.
• Contract packagers’ automation: Clinical packaging processes have become more complex with the implementation of serialization and introduction of stringent anticounterfeiting guidelines. Pharma companies are increasing automating packaging lines as a result of same.
• Eco-friendly packaging: number of drug manufacturers and clinical packaging companies are considering environmental issues while packing their product as environmental concerns are valid too.
• Anticounterfeiting packaging: DGFT of India has made it mandatory to use bar codes and unique numbers on primary-secondary packaging, along with territory packaging which is easy for tracking and tracing serialization of exported drugs.

Talking packaging is an impressive method of attracting consumers as it is a digital kind of packaging which includes HD screen on the outer packaging of the consignment, but it involves huge maintenance and distribution cost and that is why it is not trending in India along with the newness of this idea and risk factors associated with it. Progress of this industry is innovation driven which is need of this hour and it will keep on coming with fresh ideas for clinical packaging time to time.

Clinical Packaging at Bilcare Research

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.

Clinical Packaging and Machinery used

A choice of packaging machinery includes: technical capabilities, labor requirements, worker safety,maintainability, serviceability, reliability, ability to integrate into the packaging line, capital cost, floorspace, flexibility (change-over, materials, etc.), energy usage, quality of outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput, efficiency, productivity, ergonomics, return on investment, etc.

Packaging machinery can be:

1. purchased as standard, off-the-shelf
2. purchased custom-made or custom-tailored to specific operations
3. manufactured or modified by in-house engineers and maintenance staff

Efforts at packaging line automation increasingly use programmable logic controllers and robotics.

Packaging machines may be of the following general types:

• Accumulating and Collating Machines
• Blister packs, skin packs and Vacuum Packaging Machines
• Bottle caps equipment, Over-Capping, Lidding, Closing, Seaming and Sealing Machines
• Box, Case and Tray Forming, Packing, Unpacking, Closing and Sealing Machines
• Cartoning machines
• Cleaning, Sterilizing, Cooling and Drying Machines
• Coding, Printing, Marking, Stamping, and Imprinting Machines
• Converting Machines
• Conveyor belts, Accumulating and Related Machines
• Feeding, Orienting, Placing and Related Machines
• Filling Machines: Handling dry, powdered, solid, liquid, gas, or viscous products
• Inspecting: visual, sound, metal detecting, etc.
• Label dispenser
• Orienting, Unscrambling Machines
• Package Filling and Closing Machines
• Palletizing, Depalletizing, Unit load assembly
• Product Identification: labeling, marking, etc.
• Sealing Machines: Heat sealer
• Slitting Machines:
• Weighing Machines: Check weigher, multihead weigher
• Wrapping machines: Stretch wrapping, Shrink wrap, Banding
• Form, Fill and Seal Machines
• Other specialty machinery: slitters, perforating, laser cutters, parts attachment, etc.