Click Pack for Vitamin E derivatives

Manufacturers and distributors of active pharmaceutical ingredients (APIs) such as vitamins and compounds have traditionally stored and transported these substances in drums. However, a growing number have recently turned to using CurTec Click Pack nestable containers instead.

The following case study featuring leading fine chemicals supplier Isochem provides insights into what is driving this trend.

Isochem switches to Click Pack for Vitamin E derivatives

French-based Isochem S.A.S. is one of Europe’s leading contract manufacturers of fine chemistry materials and supplies. It has a 40-year track record in providing high quality ingredients and mastering complex processes. The company can manufacture products and provide services to the most recent and stringent pharmaceutical regulatory standards. The company has some 500 employees worldwide. Headquartered at Vert-Le-Petit, near Paris, Isochem has six industrial sites and is now a wholly owned subsidiary of Munich-based Aurelius AG.

Isochem serves a broad range of customers in many application fields, from leading global companies to virtual and emerging organizations, offering services in three pharma-related fields: custom synthesis, high technology manufacturing in multi-step chemical synthesis including the safe implementation of hazardous reactions, and direct supply of more than 2,300 specific compounds and products, including phosgene derivatives, functional intermediates and active ingredients.

Isochem can also provide attractive synthetic tools such as activated amino acids building blocks (N-CarboxyAnhydride) used in peptide chemistry.

Vitamin E TPGS

One of Isochem’s most important product ranges is based on Vitamin E tocopheryl polyethylene glycol succinate (TPGS), a multi role excipient used in pharmaceutical and nutraceutical applications for its proven and recognized properties to improve bioavailability of poorly absorbed drugs acting as an absorption and permeability enhancer. As a water-soluble compound, Vitamin E TPGS is also used as an efficient source of natural Vitamin E both for therapeutic purposes and nutrition in pharmaceuticals, nutraceuticals, food supplements, foodstuffs and beverages, cosmetic applications and personal care.

Switching from drums to Click Pack

Isochem had been very satisfied users of CurTec drums for packing APIs for more than 20 years, often to comply with customer requirements. Largely this was driven by regulatory requirements, to avoid incurring new packaging validation procedures, since CurTec drums had become an industry standard.

However, on current orders of Vitamin E TPGS, Isochem are now advising customers to accept delivery in CurTec Click Pack nestable containers instead.

Isochem’s Quality Director, Catherine Mercier, said: ‘It so happens that TPGS is filled hot at about 60°C, and solidifies upon cooling. Using a drum or other cylindrical shaped container as primary packaging would impede the release of the solid content.”

“So we asked CurTec for advice and they firmly recommended us to use Click Pack for packing 20 kg consignments of Vitamin E because it has a smooth interior with a semi-conical shape that allows easier emptying. In addition, the design of the container prevents the content from getting contaminated with plastic swarf and ensures that the lid cannot get damaged when closed at high temperatures,” said Ms. Mercier.

Quarter-turn sealing

A further reason for preferring Click Pack was customer convenience and protection of part-used batches.

As Catherine explained: ‘Sometimes a 20 kg batch of Vitamin E TPGS is not used all at once but consumed in smaller quantities. Customers melt the product, transfer the quantity they need and close the container again. Click Pack provides an accessible container with a sealing lid that is easy to open and close in just a quarter turn and offers convenience to its users.”

“Furthermore the container is water vapor-tight and protects the excipients because most of them are highly hygroscopic,” she added.

Designed for heavy use

Isochem’s purchasing director Christophe Saboureau focuses on cost-effectiveness.

“CurTec drums and containers are also particularly robust,” said Dr. Saboureau. “On average, our packages are handled at least 16 times before reaching their final destination. The risk of damage is very real. Sometimes bag-in-boxes and fiberdrums get damaged when the tines of a forklift truck tear open the packaging. We can prevent that kind of product loss by using CurTec drums and containers. In addition, they offer sufficient protection against moisture ingress for hygroscopic products such as NCA derivatives, which allows us to avoid degradation of its products and consequent claims from customers.”

Meeting quality demands

Isochem has a very clear view on which substances demand plastic packaging to meet quality demands.

Catherine Mercier said: “The pack should be proven food safe because most of our products are destined for the pharmaceutical industry. Suppliers should also provide proof that extractable or leachable substances are not present or well within acceptable limits in the packaging materials used.”

“CurTec not only provides all the necessary supplier declarations but also can provide documented evidence of migration tests performed on all its packaging products to meet food safety regulations,” she noted.

Cleanliness is also a vital consideration for Isochem, with CurTec preferred for maintaining a hygiene management system that allows supply of optically clean containers.

‘We fill Click Pack and CurTec drums in clean room environments. Unlike other packaging, the CurTec packs do not need to be cleaned prior to filling which not only saves us time but also cost,” said Ms. Mercier.

Thanks to:
Catherine Mercier
Dr. Christophe Saboureau
Olivier Geindreau

Resources

Click on Click Pack for Vitamin E derivatives for more information.
Click on Isochem to learn more about Curtec’s customer.
Click on CurTec to contact the company directly

Supplier Information
Supplier: CurTec International
Address: Spoorlaan Noord 92, P.O. Box 25, 5120 AA Rijen, Netherlands
Tel: +31 88 808 2000
Fax: +31 88 808 2260
Website: www.curtec.com