BACKGROUND

Static electricity is an electrical static charge, caused by an imbalance between negative and positive charges in an object. Static electricity is measured in kiloVolt(kV). This charge imbalance occurs when the imbalance becomes trapped in an object which is acting as an insulator. The imbalance won’t correct until some event lets it get out to rebalance.

Electrical charges will build up on the surface of an object such as a polythene bag until the object find a way to discharge the static energy – you can see this in dust getting attracted to machine parts or people getting electric or static shocks. The dust in the surrounding area is attracted by the electric charge imbalance.

In hazardous zones such as API plants, an uncontrolled release of a static charge can cause a spark, which in turn can cause a fire or even an explosion. Hence our customers seek to use our products to reduce risk. Ordinarily, a polythene film or bag acts as an insulator unless its properties are changed, which is what we seek to do in a controlled manner. The solution we offer is to provide a pathway for the charge imbalance to get out of the polythene bag on an ongoing basis so there is a minimal build-up of charge.

PRODUCTS

The products we make such as Liner bags, are heavy duty, with strong seals using Pharma, Food Grade polymer and specialist proprietary anti-static additives in order to comply with various regulations.

STATPAK™ is an anti-static polythene film used for the safe loading and storage of fine powder chemicals and is ideal as liner for drums or FIBC’s. It is also used in the storage and transportation of powders and tablets.

STATPAK™ (Drug Master File Number 10588) meets FDA Title 21 para. 178.3130.

Ideal for compliance with both FDA Title 21 and IEC 60079-32-1 (Para 9) for Electrostatic Powder risks in a single product solution STATPAK™ is available as bags, sacks, liners and hoods.

PROCESS AND PROPERTIES

Our anti-static film making process is more complicated than the medical plain bag process as we add additional stages and controls to our manufacturing process and carry out different testing. Please first refer to our manufacturing process schema for the core process.

We add chemicals in very controlled manner that change the properties of the very clean conventional polythene film we normally make. Polythene on its own acts a potential store of charge, as the film is an insulator and is not conductive - it does not allow the charge to dissipate.

In dust orientated environments, such as fine powders, the dust can be ignited by sparks from the bag when for example someone earths the bag by touching it or it touches a metal hopper. This leads to various regulations around the world which focus on helping to reduce this flash risk, for example ATEX directives in Europe which describe minimum safety requirements in workplaces & equipment used in explosive atmospheres. Part of this is making polythene bags less of a risk.

By introducing special chemicals, we change the physical characteristics of the polythene which make it conductive, by changing the Surface Resistance of the film to make it lower. This allows any charge built up to dissipate through the bag and onto its surfaces thus reducing the flash risk.

Keeping it simple, the chemicals we add in during the extrusion process migrate through the film to the surface, over a period of time. They will come into contact with the product being packed so hence they have to meet regulations & dosage levels. The film we make is made to be homogeneous to facilitate this migration which we have mastered over 20+ years of making this film and this gives recommended anti-static properties which last for a year, providing our recommended film storage conditions are met.

This film and bags can still be used after this year subject to retesting the films electrical properties. These chemicals have a different polarity to the water molecules in the air which are attracted to the chemical on the surface of the film. This provides a thin conductive surface layer of moisture which facilitates the dissipation of any built-up charge through this layer. Electrons are transferred out into the air, and the potential difference producing the static electricity is eliminated.

STATPAK™ is our own brand of chemicals bound in a polymer formulation which works at very low humidity levels which we add to our polythene mixes and has been in use since the early 1990s. It is in daily use around the world in many API plants, many in hot dry countries.

STATPAK™ FP is a homogenous anti-static polythene film which is effective even at low relative humidity’s (less than 12%). Designed for the particular needs of the pharmaceutical industry, it meets FDA Title 21 CFR 177.1520 (Olefin Polymers) and FDA Title 21 para.178.3130 (anti-static agents).

Some of our customers also ask us to use other anti- static additives as secondary back-ups which we are happy to oblige with (but declarations in that case must come from the additive manufacturer rather than us).

TESTING AND COMPLIANCE

All STATPAK™ product batches are tested to FTS 101C method 4046 and ASTM D-257. Complete test certification documents accompany each shipment.

We test every batch multiple time’s, to monitor the Surface Resistivity of our film to ensure the film is less than 10 ^¹² Ohms/Sq meaning it has suitable dissipative qualities. As a back-up, we also measure Charge Decay times and always, amongst other things, record the humidity on our Certificates of Analysis.

In terms of our manufacturing process, we operate under the ISO9001-2015 Standard , the BRC-IOP Packaging Standard and have a dedicated Pharma manual to cover other aspects of GMP.

As the surface of the film, bag or sheet will come into contact with the product being packaged, we have to stay within strict chemical tolerances per EEC, FDA and various Pharmacopeia legislation, hence chemical doses and blending rates are strictly controlled through using computerised gravimetric blenders to control any migration risk. We cannot for example, simply add more chemicals to get very low, test results as this would lead to possible interaction with the product being stored in the bag which would not be acceptable.

Our products are always suitability tested by our customers to ensure they do not interact with the product being stored hence why we produce both laboratory size bags up to very large drum liners.

We have been doing this for many years and hence why many global brand names are our customers. We can elaborate more on visits after NDA’s have been exchanged.

Declarations are provided for various regulations, including Pharmacopeia, EEC Food Contact, FDA Food Contact and Certificates of Analysis which lists the electrical test results for each order. We respond quickly to product development teams, to help them meet Drug Registration Packaging Requirements filings. We are regularly audited by our global customer base.