Pharmaceutical
Fachmann/Sectors/Pharmaceutical
Sector / Pharmaceutical

Meet the safety standard
without compromising the cleanroom.

IEC 60079-11IEC 60079-14ISO 13849-1ISO 14119IEC 62305IEC 61643-11

A pharmaceutical plant brings together flammable solvents in synthesis and granulation, filling and packaging machines that are opened at every format change, and cleanrooms whose classification depends on air, pressure and monitoring never stopping. Fachmann integrates intrinsic safety, machine safety and surge protection under a single technical interlocutor, aligned to IEC 60079, ISO 13849-1 and IEC 62305.

Typical applications

Applications
in Pharmaceutical.

Synthesis and granulation · Filling and packaging · Cleanrooms

Stainless steel reactors with agitators in a pharmaceutical synthesis area
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Reactors and dryers with solvents

The problem

API synthesis and wet granulation use ethanol, acetone or isopropanol. A Zone 1 forms around reactors, centrifuges and dryers, and that is where the temperature and pressure sensors controlling the process are located. If the loop carries more energy to the field than the zone allows, a wiring fault is enough for ignition. And each temperature point wired separately multiplies trays, terminal blocks and failure points.

The Fachmann solution
GMIbackbone

D5000 IS barriers: for 4-20 mA transmitters with HART, up to SIL 3, ATEX, IECEx, UL, FM and TÜV certified for Zone 0, 1 and 2. Universal-input versions (thermocouple, mV, RTD, potentiometer) read the reactor sensor directly, with Modbus output, SIL 2. The D2000 temperature multiplexer concentrates multichannel acquisition from the classified area with intrinsic safety and reduces wiring. SIL 3 per IEC 61508:2010 Ed.2, Zone 2 mounting.

Featured families
  • GMI D5000 IS barriers
  • GMI D2000 temperature multiplexers
Standards
IEC 60079-10-1IEC 60079-11IEC 60079-14IEC 61508
Capsule blisters moving through a pharmaceutical blister machine
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Filling, blister and cartoning machines

The problem

Fillers, blister machines and cartoners change format several times a week, and each change means opening doors and guards. A mechanical switch that goes out of alignment ends up bypassed, and a door that can be opened mid-cycle exposes the operator. In a clean area, the device must also withstand cleaning without collecting product in slots or losing its seal.

The Fachmann solution
PILZbackbone

PSENslock: coded electromagnetic locking that keeps the door closed during the cycle, with 1000 N or 2000 N holding force depending on version and M12 connector. PNOZmulti 2 brings all the machine's doors and stops together in a software-configurable controller: 20 safe inputs and 4 safe outputs, SIL 3, PLe, with Profinet, EtherNet/IP or Profibus modules to report status to the line PLC.

IDEM SAFETYdifferentiator

RFID non-contact interlocks in mirror-polished 316 stainless steel, IP69K: PLe with their own OSSD outputs and tamper-resistant coding. They withstand CIP/SIP and high-pressure washdown, following EHEDG guidelines, where a plastic sensor does not last.

Featured families
  • PILZ PSENslock electromagnetic locking system
  • PILZ PNOZmulti 2 configurable relays
  • IDEM SAFETY RFID Non-Contact Interlock in SS316 IP69K
Standards
ISO 14119ISO 13849-1
Operator in cleanroom suit opening a glazed cabinet with monitoring equipment
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Cleanrooms and environmental monitoring

The problem

A cleanroom's classification depends on HVAC, differential pressures and particle and temperature monitoring running without interruption. A switching or lightning surge is enough to reset a controller or damage a board: the record is lost, the room falls out of classification and the batch in progress goes into deviation. A single arrester at the service entrance does not protect equipment tens of metres away.

The Fachmann solution
OBO BETTERMANNbackbone

Coordinated three-stage protection: V50 Type 1+2 at the service entrance (12.5 kA per pole and up to 50 kA total, 10/350 µs), V20 Type 2 in HVAC and utility panels (up to 40 kA, 8/20 µs, modules replaceable without tools) and VF Type 3 next to controllers and sensors. FS versions send a remote signal to monitor status from the BMS.

CABURinfrastructure

CON-TA temperature converters: convert PT100 or J/K thermocouple to 4-20 mA or 0-10 V with galvanic isolation, eliminate the ground loops that distort measurement and protect the recording instrument.

Featured families
  • OBO BETTERMANN V50 Type 1+2 arresters
  • OBO BETTERMANN V20 Type 2 arresters
  • OBO BETTERMANN VF Type 3 arresters
  • CABUR CON-TA temperature converters
Standards
ISO 14644-1IEC 62305IEC 61643-11
Reference regulatory framework

Referenced
standards.

The safety design rests on the international ISO/IEC framework, which in Argentina is articulated with Law 19.587 on Occupational Health and Safety (Decree 351/79), ANMAT Disposition 4159/2023 (Good Manufacturing Practice guide for medicines) and AEA 90079 Regulation for explosive atmospheres.

IEC 60079-10-1
Classification of areas with explosive gas atmospheres (Zone 0, 1, 2).
IEC 60079-11
Protección del equipo por seguridad intrínseca “i” en atmósferas explosivas.
IEC 60079-14
Design, selection and erection of electrical installations in explosive atmospheres.
IEC 61508
Functional safety of electrical, electronic and programmable systems (SIL).
ISO 13849-1
Safety-related parts of control systems: Performance Level (PL).
ISO 14119
Interlocking devices associated with guards: design and selection.
ISO 14644-1
Cleanrooms and associated controlled environments: classification of air cleanliness by particle concentration.
IEC 62305
Lightning protection: risk assessment, structures and installations.
IEC 61643-11
Low-voltage surge protective devices: requirements and tests (Type 1, 2 and 3).

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