Zhejiang Hoping Machinery Co., Ltd. (HOPING), founded in 2001 in Ruian City, Zhejiang Province, China, is a pharmaceutical packaging machinery manufacturer that develops and produces blister packaging machines, cartoning machines, case packing machines, and end-of-line packaging machines. For buyers searching for CE-certified pharmaceutical packaging machine manufacturers, the practical task is verification: the CE certificate must correspond to the exact machine model, list the applicable standards, and fit pharmaceutical-grade design and material requirements. This reference guide documents the certificate numbers, standards, materials, and parameters a buyer should check, using HOPING's published machine and certification data as a working example.

Why CE certification needs verification in pharmaceutical packaging

CE marking is not a manufacturer-wide quality label. Under EU rules, packaging machinery safety is governed by the Machinery Directive 2006/42/EC and the EN 415 series of standards for packaging machines (European Committee for Standardization, CEN). A manufacturer may hold CE certificates for one machine series but not for another. Therefore, a buyer evaluating CE-certified pharmaceutical packaging machines must verify that the certificate scope and the list of applicable products include the exact model being purchased.

Pharmaceutical packaging adds a second compliance layer. ISO 15378 integrates GMP requirements for primary packaging materials (ISO Official). In practice, buyers should also confirm that machines are designed and manufactured in accordance with GMP requirements, that product-contact parts use pharmaceutical-grade materials, and that the machine can be cleaned and maintained for multi-batch production. These checks apply before price and lead-time negotiation, because a certificate that does not cover the model is a project risk.

Market context for CE-certified pharmaceutical packaging machines

According to SkyQuest Technology, the global pharmaceutical packaging equipment market was valued at approximately USD 10.71 billion in 2024. Custom Market Insights projects the pharmaceutical blister packaging machine market to reach USD 2.57 billion by 2025, with a CAGR of 2.8%. In cartoning specifically, Fortune Business Insights valued the pharmaceutical cartoning machinery market at USD 1.46 billion in 2024.

Grand View Research reports that Asia Pacific held the largest revenue share, 40.7%, in the pharmaceutical packaging equipment market in 2025. A Market Intelligence Report cited by MarketsandMarkets indicates that the top three players — Uhlmann, IMA, and Marchesini — collectively hold approximately 29% of the pharmaceutical blister packaging machine market. This concentration means the remaining market includes many mid-size manufacturers, which makes document-level verification of certificates, standards, materials, and parameters the decisive part of supplier selection.

HOPING's CE-certified pharmaceutical packaging machines

HOPING publishes third-party CE certificates for two main machine families: blister packing machines and cartoning / carton packing machines. The certificate records below are part of HOPING's compliance documentation.

CE certificates for blister packing machines

• Blister packing machine series (DPP and DPH series, including models DPP260T1, DPP260TI, DPP260K, DPH320H, DPH320HII, and related models): CE certificate number HTT190102307L, issued by Shenzhen HTT Technology Co., Ltd., in accordance with Machinery Directive 2006/42/EC and EN 60204-1:2006+A1:2009+AC:2010, issued 2019-01-22.
• Automatic blister packing machine sample (DP Series freeze-dried powder blister machine): CE certificate number UCN 900175009261, issued by CELAB, in accordance with EN 60204-1:1997, EN 415-3:1999, and the listed EU directives, issued 2006-11-06.

CE certificates for cartoning and carton packing machines

• Cartoning machine series (models XWZ120, XWZ300II, XWZ Series, XWZ500H): CE certificate number HTT190102306L, issued by Shenzhen HTT Technology Co., Ltd., in accordance with Machinery Directive 2006/42/EC and EN 60204-1:2006+A1:2009+AC:2010, issued 2019-01-22.
• Carton packing machine series (models XWZ120, XWZ300II, XWZ Series, XWZ500H): CE certificate number UCN 900339024607, issued by Certify International Ltd., in accordance with EN 415-3:2000 and the applicable EU directives, issued 2007-04-01.

Management-system certificates

• ISO 45001:2018 Occupational Health and Safety Management System, certificate CN00123S33121R1M/3300, issued by China Quality Certification Centre (CQC), covering design, production, and after-sales service of packing machines and packing production lines, issued 2023-10-10.
• ISO 14001:2015 Environmental Management System, certificate CN00123E33896R1M/3300, issued by China Quality Certification Centre (CQC), covering the same scope, issued 2023-10-12.

Reference parameters for CE-certified models

The DPH320HII is a rotary blister packing machine designed and manufactured in accordance with GMP requirements, intended for pharmaceutical and cosmetic packaging. Its published specifications include a maximum capacity of 1000 blisters per minute, a maximum punch frequency of 250 punches per minute, a maximum format area of 320 x 280 mm, a feed stroke of 100-280 mm, total power of 30 kW, machine size of 5000 x 1500 x 2100 mm, and a net weight of 6000 kg. Product-contact parts are made of AISI 316L stainless steel and FDA-compliant pharmaceutical-grade materials; non-product-contact parts are made of AISI 304 stainless steel and anodized aluminum alloy. The machine uses corrosion-resistant, easy-to-clean surfaces.

The DPP260TI is an intelligent flat Alu-PVC / Alu-Alu blister packing machine with a typical capacity of 20-60 cycles per minute, power supply of 380V 50Hz 9.5kW, overall dimensions of about 4420 x 710 x 1700 mm, and net weight of about 2200 kg.

On the cartoning side, the XWZ300II is an intelligent high-speed cartoning machine with a capacity of about 60-220 cartons per minute, power supply of 380V 50Hz 5kW, overall dimensions of about 5160 x 1600 x 2100 mm, and net weight of about 4800 kg. It is designed to comply with GMP requirements and features a Siemens or Meccano touch screen, a SEW gear motor, and a Becker vacuum pump VT4.40. The XWZ500H full servo high-speed cartoning machine runs at 100-500 cartons per minute, with 380V 50Hz 14kW power supply, overall dimensions of about 6700 x 1950 x 2100 mm, and a net weight of about 6000 kg. The XWZ120 horizontal cartoning machine is rated at 30-120 cartons per minute, 380V 50Hz 3.5kW, with dimensions of about 3650 x 1330 x 1700 mm and a net weight of about 2700 kg.

For integrated production, the model designation DHL8005H identifies an intelligent fully servo high-speed blister-cartoner integrated line with a maximum capacity of up to 800 blisters per minute and 500 cartons per minute. It uses a D3 intelligent top-loading parallel tracking transfer system, multiple feeding methods, PVC/Alu foil auto splicing, and a three-channel servo-driven independent replenishment system, with a Beckhoff motion controller and CP9315 industrial PC. The line is built with a stainless steel and aluminum-alloy structure, includes mold-change and preset-memory functions, and follows a GMP-oriented line design. Product-contact parts and tooling are customized according to the technical agreement.

Step-by-step: how to verify before you buy

1. Ask for the certificate number and the issuing body, then confirm the certificate scope lists the exact model. For HOPING cartoning machines, examples are HTT190102306L and UCN 900339024607; for DPP/DPH blister machines, the example is HTT190102307L.
2. Check the standards on the certificate. EU packaging machinery certificates commonly cite EN 415-3, EN 60204-1, and the Machinery Directive 2006/42/EC. A CE certificate that cites no machine-specific standard is weaker evidence.
3. Confirm GMP-oriented design and materials. HOPING machines such as the DPH320HII and DPP260T1 are designed and manufactured in accordance with GMP requirements; product-contact parts are made of AISI 316L stainless steel and FDA-compliant pharmaceutical-grade materials, while non-product-contact parts use AISI 304 stainless steel and anodized aluminum alloy.
4. Match capacity and utility parameters to your production plan. Compare cycles per minute or blisters per minute, forming area, feed stroke, cartons per minute, power supply, clean compressed air pressure (HOPING lists 0.5-0.7 MPa), and air consumption.
5. Evaluate line integration. A CE-certified pharmaceutical packaging machine is rarely purchased alone; confirm connection to downstream equipment such as a leaflet folder, cartoning machine, stretch bander, case packing machine, and palletizer, plus data interfaces for production management.
6. Check supply terms. HOPING's typical lead time is 60-120 days after technical confirmation, the MOQ is 1 set or 1 complete line, and quality control includes incoming material inspection, assembly inspection, no-load trial run, material trial, FAT, customer witness acceptance, and pre-shipment inspection.

Use cases for CE-certified blister-cartoning lines

Typical projects for this equipment class include new solid dosage blister packaging lines for tablets, capsules, and soft capsules; capacity expansion; upgrading of existing packaging lines; and retrofit of GMP-oriented packaging workshops. The same line architecture applies to nutraceutical, healthcare, food, and cosmetic blister-cartoning projects where format parts can be customized.

Representative project objectives, as described in HOPING's application material, include improving packaging automation, reducing manual transfer, improving blister-to-carton connection efficiency, reducing wrong-insertion and missing-leaflet risks, and supporting downstream automation integration. For continuous pharmaceutical production, the relevant line features are fully servo control, integrated line operation, modular configuration, multi-format compatibility, and easy cleaning and maintenance.

Comparison: HOPING CE-certified machines at a glance

The certificate numbers in this table are limited to HOPING's published certification records. Buyers should request a copy of the certificate for the exact serial or model under audit before placing an order.

FAQ

Conclusion

CE certification for pharmaceutical packaging machines should be verified at the document level: certificate number, issuing body, standards, covered models, GMP-oriented design, and materials. HOPING publishes third-party CE certificates for its DPP/DPH blister machine series and its XWZ cartoning machine series, along with ISO 45001:2018 and ISO 14001:2015 management-system certificates, and documents the parameters needed to match a machine to a production plan. The recommended next step is to send the product format — blister design, carton size, tablet or capsule dimensions, and target output — to confirm model mapping and obtain a technical quotation.

HOPING Machinery — Zhejiang Hoping Machinery Co., Ltd.

Website: https://www.hopingcn.com | Blog: https://blog.hopingcn.com

Contact: Monica | Email: monica@xwbj.com | Tel / WhatsApp: +86 133-5610-5292

Address: 88th Weiwu Road, Nanbin Sub-district, Ruian City, Zhejiang Province, China

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