HAPI (High Potent Active Ingredient) Manufacturing Dressing Room

In the pharmaceutical sector there is a clear tendency to develop and manufacture high potent products, currently they represent  35% of the global market share and 50% of products under development (Class 3 and 4 Safebridge classification).

New areas or adaptations of current areas are going to be necessary to manufacture these kinds of products, the design and installation of the personnel dressing rooms for these areas is going to be critical.

In this blog we want to focus on the design of the HAPI areas, dressing rooms or with GMP special requirements for new areas or areas that must be adapted to manufacture these kinds of products

HAPI general considerations

2 items must be considered:

• Cross contamination between different products, less quantity of contamination can produce an undesirable pharmacological effect in the final patient.
• The potential exposure of the operators to the HAPI products, less quantities of exposure can produce undesirable effects in the operator.

HAPI area design

In the design of a HAPI area, different aspects must be taken into consideration, a risk map and risk analysis must be done in order to evaluate and apply contention and mitigation aspects.

In our blog we want to focus on the dressing rooms

High powered dressing rooms

The HAPI personnel dressing rooms must comply with

• • Restrictive access control in order to only allow entry to approved and trained personnel to the manufacturing area
  • Locked doors that prevent two zones from coming into contact.
  • Minimize the risk of exposure of the operator in the dressing procedures.
  • Guarantee the availability of protection equipment to the personnel.
  • Containment and segregation of the high powered areas

 HAPI dressing rooms design

The design must be as follows:

Entrance dressing room

• The first room must have a double door locker locked between the entrance and exit dressing rooms, in this first room the operator puts on the protected gowning and leaves the shoes and the general gowning.
• This room has a higher pressure in comparison with the entrance hallway and the second entrance dressing room.
• Before the entrance to the manufacturing area the operator must pass to a second dressing room in order to get the personnel protection equipment and the contention area shoes and he/she will verify that he/she is correctly dressed before the entering into the manufacturing area.
• This room has a higher pressure in comparison with the manufacturing area.

Exit dressing room

• In the exit there will be a nebulizer shower, to fix the potential contamination to the clothes
• From the nebulizer shower the operator will access a first dressing room in order to take off the protected gowning (they will be considered as a residues or they will be put in a bag in order to be decontaminated and washed in an appropriate installation), the shoes will also be taken to be cleaned and decontaminated as will the personnel protection equipment.
• From the first dressing room the operator will pass to a second room, in the room the operator can get the shoes and the general gowning
• The second dressing room will have a higher pressure compared to the first dressing room.
• The exit dressing rooms must be cleaned more often, have more air changes, and more residue removals than traditional manufacturing zones.

Nebulizer showers

Important equipment to assure the operator’s security in the gowning procedures and also to assure the contention of the HAPI area.

The function of the nebulizer shower is to encapsulate and fix the potential contamination that could be on the gowning in order to prevent the operator from inhaling any contamination while undressing.

The nebulizer showers allow the operator not to get soaked and make the gowning procedure easier.

Ingelyt  has a lot of experience in the design, construction and installation of nebulizer showers.

 

Tags: High potent, manufacturing dressing room