Handling materials in pharmaceutical manufacturing is challenging, time-consuming and costly. Many manufacturers repeatedly struggle with the same issues — even designing whole facilities to work around handling problems. The team behind PuroVaso saw an opportunity to design an entirely new solution for moving and storing that was better suited to modern manufacturing processes. Here, they tell us more…
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Moving and storing powders, granules, tablets and capsules can be a challenge. Available containers range from cumbersome to fiddly. Fibre drums are difficult to keep clean. Stainless-steel containers are heavy. IBCs are huge. Cardboard boxes are easily damaged. Plastic bags and liners are flimsy.
These solutions are often expensive requiring capital investment, or single-use and environmentally unsustainable. Most are difficult to handle requiring more capital equipment. The problem is never more evident than when operators are forced to use a lifting hoist or a stacker truck to handle very small volumes of active ingredients that could easily be handled manually.
Working around these challenges takes a great deal of care and adds a lot of time to each manufacturing process.
A broad range of criteria
PuroValve
As reported by Health and Safety Executive (HSE) manual handling within pharma accounts for two thirds of instances involving the reporting of injuries, diseases and dangerous occurrences regulations (RIDDOR’s).1To make this aspect of a working environment safer however, is not simply a case of reducing the weight that is to be handled manually there are many other important contributory factors.
Looking at a broad range of criteria is integral in the design of a container solution that meets the needs of modern pharmaceutical manufacturing. From the container material to its overall ease of use — below we break down the major considerations, highlighting their importance to design and handler safety.
Material
Making a container for any form of handling requires a certain level of fore-thought, will the contents be heavy/light, hot/cold, will they react to certain compounds/materials, etc. This factor is of great import to pharmaceutical ingredients, which are governed themselves by strict regulatory guidelines and therefore should be kept at optimum condition while in storage or in transit.
Suitable materials for use in such containers include those that are manufactured from US, EU and UK regulatory compliant starting materials and that meet various regulatory bodies’ requirements.
One such example is anti-static polyethylene, which is used in standard PuroVaso containers. This is recognised as one of the most chemically suitable materials for pharmaceutical manufacturing and is also suitable for ATEX dust environments. To help visualise the fill level of the container it is possible to use a translucent opaque white formulation and in cases where UV protection is required a pure white formulation can be used.
PuroVaso image 1
Conductive polyethylene can also be employed, allowing electrostatic charges generated by the powders or granules to be dissipated. This material is particularly relevant for micronized APIs, electrostatic static sensitive excipients or for higher risk ATEX dust and gas/vapour environments.
Using a material like polyethylene in a container affords multiple advantages. Not only is it lightweight compared to other materials but it is also structurally stable. These benefits mean that handling of the container is made easier while also ensuring protection of the product contained as it can sustain being dropped without the risk of leaking or spilling.
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Task
Thinking about the duration of time a container will need to be handled as well as how often is important in container design. As mentioned above, use of a lightweight yet sturdy material is greatly beneficial but the size of the container and the ergonomics should also be thought about.
Containers should be small enough that they are easy to carry whether full or empty. Having a square shape means they should fit into usually limited storage space in containment facilities but using rounded edges also minimises any potential risk of slipping when loading.
Ease of use and environmental factors
Ensuring flexibility for the users’ requirements is also important. The neck of the PuroVaso container, for example, includes an industry standard tri-clamp ferrule, which allows any valve to be fitted. Additionally, a full range of ancillary devices means the containers can be interfaced with all existing pharma equipment.
Whether single-use or multi-use, products nowadays should be designed to meet requirements while avoiding adverse impact on the environment. If designing a single-use product then using a fully recyclable material is advantageous. For multiple use products then ability to clean appropriately is an important consideration.
Having a large internal radius and rounded corners helps facilitate cleaning and the material used should be able to withstand cleaning at high temperatures with detergents and sterilising agents. Further to these requirements, PuroVaso has been designed so that sterilisation with VHP or gamma irradiation can be performed.
Summary
It isn’t easy to develop an entirely new consumable product for use within the pharma sector. Many factors need to be considered in the design process. Ensuring that not only cost is viewed but also the practicality and safety for the day-to-day use is definitely imperative.
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