アルマック・ファーマシューティカル・サービス株式会社

シリアライゼーション・管理・追跡

偽造医薬品対策を主導

Almacのシリアライゼーションシステムは、オーバープリントによるシリアライゼーションと検査体制を組み合わせることで、GS1規格を遵守しています。製造から輸送に至るまで、サプライチェーン全体のトレーサビリティを向上させるため、2次元バーコードを採用し、カートンや密閉式の容器にシリアル化した個別データを記載することで、パレット単位での集約化を行います。

Specialised Packaging Solutions

With more than 50 years’ experience, we offer a wide range of specialised packaging solutions to meet your product launch and ongoing commercial supply needs. Addressing the increasing focus of developing and bringing more advanced medicines and niche orphan drugs to market, we continue to invest in our commercial packaging capabilities to provide enhanced specialised packaging services to our client partners.

Pack Design & Prototype Generation
Our dedicated in-house packaging design team can provide full lifecycle support of all your pharmaceutical packaging needs. From initial regulatory data and texts, early stage artwork mock–ups with concept development through to full support of post-approval update activities. A wealth of packaging design experience and practical knowledge ensures we deliver innovative packaging solutions to meet regulatory requirements and patient needs and expectations.

Vial, Syringe & Complex Medical Kit Assembly
We offer a range of secondary labelling and packaging solutions for biopharmaceutical products including vials, ampoules, pre-filled syringes, pens and medical devices. With bespoke kit assembly technology our Semi- Automated Packaging System (SAPS) provides a best-inclass, streamlined and efficient packaging solution for the specialised packaging of complex pharmaceutical kits, medical device components, combination products and biologic packs.

Paediatric Packaging
Complementing our experience in developing and manufacturing Paediatric dosage forms, we can provide innovative, child resistant specialised packaging in the form of stickpack capability. Stickpacks are an ideal presentation for common Paediatric dosage forms such as minitablets, granules and powders, providing Paediatric patients a measured unit dose ensuring uniform dosing and when presented in a secondary wallet can aid compliance.

Rapid Launch
Helping you meet an unmet patient need as soon as possible after FDA approval, the specialist team at our US commercial packaging facility can have saleable, packed product with your distributor within 24 – 48 hours of approval. The success of our Rapid Launch service is made possible by our robust standardised procedures, which have been developed and put into practice by an experienced multi-disciplinary team of subject matter experts. These procedures, together with strong project management enables Almac to pack and launch your product within a 24-48 hour timeframe from FDA approval.

Serialisation
Addressing evolving global serialisation legislation, Almac’s expert multi-disciplinary serialisation team lead the way in supporting clients in developing and implementing their serialisation strategies to GS1 standards.
Providing flexible serialisation solutions to meet all your serialisation needs, our partnership with Optel ensures our serialisation technology not only meets but surpasses current serialisation legislation and is adaptable to all upcoming regulations. Almac have over 9 years’ experience in developing and delivering serialisation solutions to secure our clients global supply chains.

Humidity Sensitive Product Packaging
Providing protection to humidity sensitive drug products our specialised relative humidity (RH) controlled blistering suites, pack your environmentally sensitive tablets / capsules into specialised blister packaging. RH can be maintained as low as 20%, ensuring your drug product is protected from external influences, guaranteeing optimum quality.

Orphan Drugs
When speed and agility are imperative to ensuring your valuable drug product reaches the patient as quickly as possible, our UK & US commercial packaging facilities are highly flexible to accommodate niche packaging campaigns. Whether that be, just-in-time processing of regionalised packs in Europe or specific on demand blister printing, our experienced and responsive project managers are able to
support all your orphan drug packaging needs.

Customised Solutions
We have a dedicated in-house engineering team who provide tooling design, fabrication and machine prototype manufacture. Their expertise facilitate a rapid turnaround of tailored solutions and equipment design & build to meet the requirements of your specialised product.

Capital Projects

Almac has a leading reputation for delivering complex, time sensitive capital projects in support of increasing innovative drug products. We have invested in the following specialised packaging technologies at our UK & US commercial packaging facilities:

• Design and installation of a bespoke Semi-Automated Packaging System (SAPS) for the packaging of complex medical kit components including both standard and custom syringes and auto-injector pens
• Installation of a dedicated Relative Humidity (RH) controlled blister suite and an offline HAPA digital print unit to facilitate on demand blister printing for smaller markets
• Addition of a Merz stickpack line which is a fully automated forming, filling and sealing machine, capable of filling stickpacks with powders, granules or minitablets