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Aire & Gas para Procesos Farmacéuticos

Trace Analytics, LLC – el Laboratorio Líder en Análisis de Aire Comprimido Desde 1989

Aire & Gas para Procesos Farmacéuticos

El aire comprimido es una utilidad sumamente importante usada ampliamente en los procesos de manufactura farmacéutica y es usado directa e indirectamente con productos farmacéuticos. El análisis periódico de sistemas de aire comprimido y otros gases que entran en contacto con productos farmacéuticos es crítico para garantizar la calidad e integridad del producto.

En Trace Analytics, nuestro equipo de expertos se dedica a proporcionar aire limpio con los estándares de calidad más altos, y al mismo tiempo, ofrecer orientación a los fabricantes farmacéuticos cuando no hay criterios de análisis claros.

En la ausencia de un determinado estándar, se les recomienda a los fabricantes de productos farmacéuticos guiarse en los estándares de International Organization for Standardization (ISO) 8573-1:2010 (La Organización Internacional de Normalización) además de hacer un plan para llevar a cabo análisis de aire periódicos para mantener la pureza de aire adecuada. La clase de pureza de ISO 8573 elegida por las instalaciones de manufactura dependen del uso del aire comprimido y su contacto con el producto. La fábrica debe empezar por llevar a cabo un análisis de peligros, el cual ayudará al fabricante a identificar peligros probables del aire comprimido, evaluar las medidas de control ya en existencia y determinar si se necesitan controles adicionales.

Lo que Ofrecemos

Ofrecemos límites y especificaciones personalizadas diseñadas para satisfacer las necesidades de análisis de cada cliente así como orientación para los fabricantes en la navegación de los requisitos del análisis. Nuestros kits son confiables, exactos, y fáciles de usar y cumplen con los requisitos de recolección y análisis de la norma ISO 8573-1:2010, garantizándoles a los fabricantes la calidad de su producto final.

Normas de Análisis de Aire Comprimido & para la Industria Farmacéutica

En Trace Analytics, LLC hacemos análisis para verificar el cumplimiento de una gran variedad de normas y especificaciones. Algunas de las normas más usadas en la industria farmacéutica son:

ISO 8573-1:2010 Compressed Air Contaminants and Purity Classes

ClassParticlesWaterOil
By Particle Size
(maximum number of particles per m3) See Note 2
By MassVapor Pressure DewpointLiquidLiquid, Aerosol, & Vapor
See Note 1
0.1 µm < d ≤ 0.5 µm0.5 µ m< d ≤ 1.0 µm1.0 µm < d ≤ 5.0 µmmg/m3°C°Fg/m3mg/m3
0As specified by the equipment user or supplier and more stringent than class 1
1≤ 20,000≤ 400≤ 10-≤ -70≤ -94-≤ 0.01
2≤ 400,000≤ 6,000≤ 100-≤ -40≤ -40-≤ 0.1
3-≤ 90,000≤ 1,000-≤ -20≤ - 4-≤ 1
4--≤ 10,000-≤ +3≤ +37-≤ 5
5--≤ 100,000-≤ +7≤ +45--
6---0 – ≤ 5≤ +10≤ +50--
7---5 – ≤ 10--≤ 0.5-
8------≤ 5-
9------≤ 10-
X---> 10--> 10> 5
 Microbiological ContaminantsOther Gaseous Contaminants
 No purity classes are identifiedNo purity classes are identified
Gases mentioned are: CO, CO2, SO2, NOX, Hydrocarbons in the range of C1 to C5

Note 1: ISO 8573 Oil includes aerosol, vapor in the range of C6+, and liquid oil. Liquid oil is typically sampled when wall flow is present, contamination is suspected, or results are greater than 5 mg/m3. Trace can provide a separate kit for liquid oil testing.

Note 2: For Particle Class 0, 1, & 2 (0.1 - 0.5 µ range only), a laser particle counter with a high-pressure diffuser is required. Rental of this equipment is available on a reservation basis. Contact us for details. To qualify for Particle Classes 0 through 5, there can be no particles greater than 5µ present.

In some cases, Trace uses alternative sampling techniques or analytical methods to those specified in ISO 8573, for details see Smith White Paper, 2012.

Air & Gas Specifications referenced above may be viewed and/or purchased from: ANSI - American National Standards Institute

2011 ISPE Good Practice Guide - Process Gases, Table 7.1

ParticlesWaterOil
By Particle Size
(maximum number of particles per m3)
By MassAerosols or Vapor Pressure DewpointLiquidHydrocarbons
0.10 µm < d ≤ 0.5 µm0.5 µm < d ≤ 1.0 µm1.0 µm < d ≤ 5.0 µmmg/m3°C°Fg/m3mg/m3
Viable and Non-Viable Count Typically equal to the at rest condition of the area served≤ -40≤ -40-≤ 0.5
Microbial CountOther Chemical Impurities
Non-Sterile ApplicationsSterile Applications(Only as Applicable) Based on the generation technology and/or USP/EU Monograph
Guideline limits to be established based on product bioburden limits. Typical level NMT 5 cfu/m3As per viable particle requirements for Grade area where the product is exposed to the compressed gas (e.g., Grade A, Grade A/B, Grade B or Grade C)Gas Purity
Applicable for inert gases such as Nitrogen, as per USP/EU Monograph
Air & Gas Specifications referenced above may be viewed and/or purchased from: ISPE - International Society of Pharmaceutical Engineering

Cleanroom Classifications a

Clean Area Classification
(0.5 µm particles/ft3)
ISO Designation b≥0.5 µm particles/m3Microbiological Active Air Action Levels c
(cfu/m3)
Microbiological Settling Plates Action Levelsc,d
(diam 90mm; cfu/4 hours)
10053,520ee
1,000635,20073
10,0007352,000105
100,00083,520,00010050
  1. All classifications based on data measured in the vicinity of exposed materials/articles during periods of activity.
  2. ISO 14644-1 designations provide uniform particle concentration values for cleanrooms in multiple industries. An ISO 5 particle concentration is equal to Class 100 and approximately equals EU Grade A.
  3. Values represent recommended levels of environmental quality. You may find it appropriate to establish alternate microbiological action levels due to the nature of the operation or method of analysis.
  4. The additional use of settling plates is optional.
  5. Samples from Class 100 (ISO 5) environments should normally yield no microbiological contaminants.

Recommended Limits for Microbial Contamination a

GradeAir Sample cfu/m3Settle Plates
(diameter 90mm)
cfu/4 hours b
Contact Plates
(diameter 55mm) cfu/plate
Glove Print
5 fingers
cfu/glove
A< 1< 1< 1< 1
B10555
C1005025-
D20010050-
  1. These are average values.
  2. Individual settle plates may be exposed for less than 4 hours.
Air & Gas Specifications referenced above may be viewed and/or purchased from: ANSI - American National Standards Institute