アルマック・ファーマシューティカル・サービス株式会社

商用包装

経口固形製剤の包装および無菌提供に関する各種ソリューションをご用意しています。大型医薬品からオーファンドラッグまで、さまざまな規模の上市や供給をサポートします。

一次包装は、ボトル、ブリスター包装（高温成形および低温成形）、分包、スティックパックに対応します。またバイアル、アンプル、シリンジ、ウォレットならびに複雑なキットの組み立てが必要な製品の二次包装、ラベリング、組み立ても行います。

Almacは、下記のような条件に対応できる高度な包装技術を有しています。

• 湿度の影響を受けやすい製品
• 複数の製品を組みあわせたブリスター包装
• 大型のブリスター包装

ブリスター包装ラインでは、HAPA社のブリスター印刷技術を用いたジャストインタイムの包装が可能です。費用を削減しながら、柔軟に対応いたします。

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Commercial Packaging Solutions

With more than 50 years of experience, we offer a wide range of tailored commercial packaging solutions and global expertise, to meet your product launch (including rapid launch) and ongoing commercial supply needs.

Primary Packaging of capsules, powders, liquids, and granules (mini-tablets)
• Bottles
• Blisters (thermoform and cold form) - Online blister printing
• Sachets, and stick packs

Secondary Labelling, Packaging and Assembly
• Bottles
• Vials
• Ampoules
• Syringes
• Wallets / blister cards
• Auto-injectors
• Cartons
• Packing sachets
• Packing stick packs
• Offline blister printing
• Complex kit assembly

Advanced packaging technologies
We support the unique demands of our clients with advanced packaging technologies capable of processing:
• Humidity sensitive products with desiccant insertion
• Multi-product combination blisters

Our blister lines incorporate HAPA blister printing technology for both online and offline blister printing, adding flexibility, reducing cost, and supporting just-in-time (JIT) packaging.

Ultra Low Temperature
Working collaboratively with our clients, we specialise in providing innovative, tailored solutions supporting advanced therapy product launches, Just in Time labelling, packaging at ultra low temperatures, QP release and 3PL supply chains.

Semi- Automated Packaging System (SAPS)
The custom built SAPS line provides a streamlined and efficient semi-automated process for the packaging of complex medical kit components and can process syringes, auto-injector pens and any other medical devices. The highly customisable technology can operate to various scales, allowing for a variety of pack formats from sample kits to marketing packs in addition to multi-product dosage packaging.

Packaging and Artwork Design
With access to the most up-to-date design hardware and software, our dedicated in-house packaging and design team is able to provide a full suite of design services to meet your requirements. Generating the artwork in-house streamlines the approval process and saves time and money whilst ensuring regulatory submission deadlines are met.

Serialisation and Track & Trace
Our product serialisation system ensures compliance to GS1 standards. Facilitating traceability throughout the distribution supply chain, the system applies and verifies 2D matrix barcodes and serialised data to individual cartons / saleable items and can support full aggregation to pallet level.

Dedicated project management
A dedicated New Product Introduction (NPI) Project Manager is assigned to each client partner, easing the transfer of all commercial packaging projects. This single point of contact leads an experienced, multidisciplinary team through a transfer process that is seamless, clear, and defined.

GMP Storage
To meet all your storage requirements, we have multiple, modular Good Manufacturing Practice (GMP) warehousing and storage capabilities for raw and in-process materials and finished goods. Significant
frozen/ultra-low temperature -20°C, -40°C, and -80°C and refrigerated (2–8°C) storage units complement our controlled ambient (15-25°C) storage capabilities. In addition, our Drug Enforcement Administration (DEA) and UK Home Office accreditation allows us to store schedule II-V controlled substances.

Paediatrics
Complementing our experience in development and manufacture of Paediatric dosage forms, we can offer innovative, child resistant specialist packaging. Our stickpack, sachet, powder in bottle, and liquid in bottle lines are configured to facilitate the packaging of common paediatric dosage forms such as minitablets, granules, powders, and liquids.

CBE-30 Filing
With significant experience in supporting Changes Being Effected 30 (CBE-30) filings and the ability to provide a smooth transfer of operations, our commercial packaging facilities are equipped to provide cost-effective and reliable product supply solutions. This ensures your product reaches the marketplace on time, in full.

Rapid Launch Packaging
Our specialised teams can pack and distribute your drug product to US, EU, and ROW markets within 24-48 hours of regulatory approval.

Repackaging
Should your product need to be repackaged quickly (due to updated packaging components, revised regulatory requirements, new Stock Keeping Units (SKUs), and / or revised marketing strategies), our specialist team can help ensure minimal disruption to your product supply chain.

Capital Projects
Almac has a leading reputation for delivering complex, time sensitive capital projects, in support of growing innovative products. We have co-invested with our client partners in excess of $15M to support many of their project pipelines.

GMP Floorspace
Flexible GMP floorspace provides the ability to facilitate reserved capacity models for long term projects and rapid launch models.

End-to-end supply
Almac Pharma Services offers a range of fully integrated product development, clinical and commercial manufacturing solutions from our new state of the art facility. Providing both small and large scale
manufacturing, and technology transfer to provide a smooth transition of your product.

Our tailored, quality-led end-to-end solutions enables us to support your team from a single source as you move from early to late-stage development through to launch and commercial supply across global markets.

Why choose Almac?

• Highly experienced, dedicated, and expert teams
• Industry leading project management
• Flexibility to meet your growing needs
• Reputation for quality
• Results driven
• Collaborative partnership
• One global Quality Management System
• Continual investment in our people, facilities, capabilities, and technology