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Vial Labelling System - HERMA132M HC


- HERMA 어플리케이터 및 라벨링 기계는 신뢰성, 정밀도 및 속도로 수십 년 동안 제약 라벨링에서 가장 까다로운 작업을 처리해 왔습니다.

- 표준화 된 모듈과 정교한 모듈 식 디자인을 갖춘 HERMA 라벨링 기계는 항상 개별 생산 조건에 맞춰 재현 가능한 결과를 제공합니다.

- 모든면에서 HERMA는 현재와 미래의 요구 사항을 충족 할 수있는 확실한 기반을 제공합니다.

- 최대 속도 : 600vial/ min

의약품 라벨링의 안전

제약 생산에서, 어떠한 품질의 일탈도 사람이나 동물의 건강에 직접적인 영향을 미치게 됩니다.

그렇기 때문에 우리는 설비를 통해 부착되는 라벨링 과 인쇄, 코딩에 있어 최대한의 신뢰성을 강조합니다.

HERMA는 포괄적인 GMP 지침에 따라 표준 제어 시스템, 일련화, 변조 확인 라벨링 솔루션 및

기계 설계를 포함하여 강력한 전체적인 패키지를 제공합니다.

1. 신뢰할 수있는 제어 시스템

HERMA 제약 라벨부착기는 가장 엄격한 요구 사항을 충족하고 작동 오류를 근절하도록 설계되었습니다.

우리의 목표는 정품으로 판명 된 제품과 라벨만 생산 공정에 남아 있도록하는 것입니다.

모든 고객 요구 사항을 충족하기 위해 HERMA 시스템의 모듈 식 설계에는 모든 종류의

기존 센서 및 카메라 시스템을 통합하기위한 표준화 된 브래킷이 포함되어 있습니다.

이중 제어 시스템은 사람들이 수동으로 시스템을 우회하는 것을 방지합니다. ( CFR21 PART11 등)

또한, 마지막 불량제품 제거 파트에서는 완전하게 성공적으로 제거 되었는지 교차 점검을 통해 완벽하게 검증합니다.

2. 종합적인 문서 제공

- 우리는 고객과 협력하여 적격성 평가 마스터 플랜 및 프로젝트의 적격성 평가 계획을 준비하여 제공 합니다.

- 우리는 예를 들어 하드웨어 및 소프트웨어 사양에서 프로세스 검증을 위해 고장 모드의 영향 분석 (FMEA)과 추적 성 매트릭스를 사용합니다.

- 프로세스 최종 단계의 핵심 요소는 설치 적격성 평가 (IQ), 운전 적격성 평가 (OQ), 와 FAT 및 SAT입니다.

3. Design of our High-Performance Labeling Machines

Whether you need labels with tear-off flaps, hanger labels for infusion bottles or booklet labels: HERMA labeling machines are especially suitable for covering a wide range of products and applications reliably ? and for meeting the very specific requirements of pharmaceutical labeling.

  • Their modular design lets you change format parts quickly and in most cases without needing tools.
  • In terms of line clearance, HERMA machines are optimized to ensure a clean and smooth process sequence.
  • The long-term, worldwide and online availability of spare-parts ensures a high level of investment security.
  • HERMA labeling machines have a compact design that makes them easy to integrate into existing packing and packaging systems.
  • Process and production excellence are crucial to maintaining the high quality of our applicators and labeling machines. Our new production facilities in Filderstadt, Germany are setting new benchmarks in this regard.The High Requirements Placed on Pharmaceutical Labeling Solutions

Medication is as lucrative a field of business as ever for counterfeiters.

The EU Commission has responded to this threat with the Falsified Medicines Directive

2011/62/EU that came into force on February 9, 2019, and has provided pharmaceuticals companies

with strict requirements for identifying and tracing pharmaceuticals and protecting them from manipulation.

We have developed some hugely effective solutions for serialization, track and trace, aggregation and tamper-evident labeling.


To comply with the Falsified Medicines Directive, all packaging for prescription medication brought to

market within the EU must have a unique, individual serial number.

The numbers are generated by official organizations, regulated and stored in a database.

Similar solutions are being considered or have already been implemented in many other markets.

  • -Special precautions are required to record the serial numbers or 2D code of rejected labels or packaging.
  • Such labels or packaging must not be made available or should be made available only with checks.
  • HERMA labeling machines can be fully equipped to perform serialization tasks in medicine labeling in compliance
  • with EU regulations or other international provisions.
  • Aggregation (that is, the aggregation of serialized products) is often necessary or
  • useful in combination with serialization. The HERMA product portfolio includes the perfect printing
  • and applicator systems for this task.

Track & Trace

Where does the product come from? Who produced it? In many markets,

the path taken by a drug must be fully traceable at all times ?

from the manufacturer to the end consumer. Track and trace lets you record its full route along the supply chain in real time.

One prerequisite for doing so is that the product can be clearly identified by a serial number.

HERMA provides you with powerful printing and labeling solutions for the special requirements involved in track and trace.


Aggregation is the secure combination of individually serialized packages into larger logistical units such as bundles,

cardboard boxes or pallets. Unlike the serialization of individual packages, aggregation is not a legal requirement in the EU,

although it is in other markets. However, it offers pharmaceutical companies another added benefit:

establishing a relationship between the individual products and the logistical units makes it much easier to

trace the path of individual medications. That also makes it easier to coordinate recalls or report stolen products, for instance.

  • To print the aggregated “group codes” on labels and apply them, HERMA offers particularly reliable print and apply systems for every aggregation level.


The EU and many other markets stipulate that pharmaceutical packaging for medicines such as prescription drugs, for instance, requires a tamper-evident seal as a security feature. If you wish to continue using your current folding boxes, the use of tamper-evident labels is a particularly interesting option.

  • HERMA offers a range of efficient and reliable solutions for sealing packaging with seals or tamper-evident labels. Our specially developed tamper-evident labeling machines are already deployed in a large number of markets.
  • Where transparent tamper-evident labels are used, the adhesive with luminescent particles can be adjusted to enable a UV sensor on the labeling machine to detect the difference between the folding box and label. This allows you to check the successful application of the tamper-evident labels directly.
  • If the tamper-evident labeling is printed on, a camera system or contrast scanner can perform this control function.
  • If none of these methods work, gloss sensors can be used to detect any difference between the gloss on the folding box and the gloss on the tamper-evident labeling labels, and therefore determine the presence of the labels.

GMP Standards

Quality assurance plays a central role in the manufacture of medication, with direct effects on patient safety. A quality management system in accordance with GMP (“Good Manufacturing Practice”) helps to ensure product quality and the obligatory fulfillment of healthcare authority requirements.

    • HERMA pharmaceutical labeling machines are developed and built in accordance with GMP requirements. This is how they help to achieve the prescribed quality levels in the production processes and environment.
    • The provisions can vary from country to country.
    • GAMP (“Good Automated Manufacturing Practice”) is another closely associated standard. It includes guidelines (which are not legally binding) for codes and programming machine controls. Its aim is to rule out undesirable functions from the outset.

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