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WHY PEOPLE, PARTICLES, AND PPE MATTER IN HOSPITAL PHARMACIES

Joshua Stevens
Joshua Stevens
Workers in protective gear handling sensitive pharmaceutical products

Why does ‘Clean’ Matter?

Clean matters in hospital pharmacies because any contamination in the environment can directly compromise the safety, sterility, and quality of medicines, especially injectable and aseptically prepared products, putting patients at risk of infection or toxic exposure.


Where is the Contamination Risk to a Clean Room?

Humans are regarded as the largest single risk to cleanliness in pharmacy cleanrooms and aseptic units. A person sheds dead skin cells (in the form of microscopic skin flakes) at a rate of about 1 billion flakes per day, and the typical flake of skin is about 35 microns in diameter. As a result, protective apparel is a critical element to preserving the integrity of the cleanroom environment and the people and products within these environments.

This highlights the importance of Personal Protective Equipment (PPE) to not only protect personnel but also safeguard products and processes from contamination.

We shed approx 100,000 particules per minute sitting

Sitting:

We shed approx 100,000 particules per minute

We shed approx 1,000,000 particules per minute walking

Walking:

We shed approx 1,000,000 particules per minute

We shed approx 10,000,000 particules per minute running

Running:

We shed approx 10,000,000 particules per minute

What are the Classifications for a Clean Room?

To meet requirements of a cleanroom, the air within an enclosed space must not exceed a particulate count as detailed by that room's specific ISO classification, which is described by ISO 14644-1:2015. The basis of cleanroom standards is the micrometer or micron. Each ISO classification allows a certain maximum number of particles per m3 of air. The cleanroom environments are divided into classifications known as ISO 1 through 9. ISO Class 1 is considered the ‘cleanest’ while ISO Class 9 is considered the ‘dirtiest’.

ISO Classification number Class Limits (particles/m³)
Maximum concentration limits (particles/m³ for particles equal to or larger than the considered sizes below
0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm
ISO Class 1 10 2
ISO Class 2 100 24 10 4
ISO Class 3 1,000 237 102 35 8
ISO Class 4 10,000 2,370 1,020 352 83
ISO Class 5 100,000 23,700 10,200 3,520 832 29
ISO Class 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO Class 7 352,000 83,200 2,930
ISO Class 8 3,520,000 832,000 29,300
ISO Class 9 35,200,000 8,320,000 293,000


Are Sterile Gloves Enough for Clean Rooms?

Not all sterile gloves are created equal. Both cleanroom and medical gloves can be sterile, however their differences lie in how they are manufactured, tested, and used, depending on whether the focus is contamination control or patient protection.

Sterile medical gloves are designed to protect patients and healthcare providers during clinical procedures, they are not suitable for cleanroom environments due to their lack of clean processing and particulate control. In contrast, clean and sterile cleanroom gloves are manufactured and packaged to meet the stringent cleanliness and contamination control standards required in life sciences and critical cleanroom applications. The difference between Clean & Sterile Cleanroom Gloves Vs Medical Sterile Gloves are displayed in below table.

Category Clean Cleanroom Gloves Sterile Cleanroom Gloves Sterile Medical Gloves
Definition Disposable gloves manufactured in cleanroom environments with low particulate, chemical, and microbial contamination. Undergo the same manufacturing as clean gloves including validated sterilization processes, designed for aseptic cleanroom applications. Medical-grade disposable gloves are sterilized for use in surgical, diagnostic, and patient care environments.
Primary Purpose Designed for contamination control in cleanrooms where product integrity is critical, but sterility is not required. Provide both contamination control and sterility, ideal for aseptic manufacturing and sterile cleanrooms. Protect patients and healthcare professionals from biological contamination, especially during medical procedures.
Manufacturing Environment Post processed and packed in ISO-classified cleanrooms (e.g., ISO Class 7 or 8) following stringent cleanliness protocols. Post processed and packed in ISO 5 and higher cleanrooms and sterilised with validated sterility assurance levels (e.g., SAL 10⁻⁶). Manufactured under regulated medical device environments per FDA, EN 455, or ASTM D3577 standards.
Post-Processing Methods Gloves are rinsed with deionized water to ensure low residual contamination. Undergo the same processing as clean gloves, followed by sterilization via gamma irradiation or ETO. Typically sterilized but not subjected to cleanroom rinsing or particle/ion reduction processes.
Packaging Format Packaged in non-linting, cleanroom plastic packaging, typically double-bagged with carton liners for clean transfer. Double or triple-bagged carton liners for aseptic transfer and handling. Packaged for sterile clinical use but not designed for cleanroom compatibility, clean handling, or low-shedding materials.
Sterility Non-sterile; not suitable for aseptic tasks but ideal for particulate control. Sterile, suitable for high-risk cleanroom environments requiring aseptic handling. Sterile, suited for clinical, surgical, and diagnostic use where infection prevention is critical.
Shelf Life & Storage Requires clean, dry storage away from UV and contaminants to maintain low particulate integrity. Requires sterile storage with validated shelf life. Requires dry, temperature-controlled storage to maintain sterility and material integrity.
Common Applications • Semiconductor and electronics manufacturing
• Optical device assembly
• Research & lab work 		• Aseptic pharmaceutical production
• Sterile compounding (hospital cleanrooms)
• Cell & gene therapy 		• Surgical operations and procedures
• Patient examinations
• Medical diagnostics and wound care


How do I Select Clean Room Apparel?

Follow IEST-RP-CC003.4 a recommended practice guide for “Garment system consideration for cleanroom and other controlled environment”. Which recommends the best practice for the gowning of personnel as a critical aspect of cleanroom contamination control. The table below is guidance for the selection of cleanroom apparel and accessories appropriate for use in various ISO class of cleanroom and controlled environment.

EN ISO 14644-1 Classification Number
APPAREL 1 & 2 3 4 5 6 7 8
Hood ○ ✓ ✓ ✓ ○ ○ ○
Coverall ✓ ✓ ✓ ✓ ✓ ○ ○
Over-boots ✓ ✓ ✓ ✓ ✓ ○ ○
Overshoes X X X X ○ ✓ ○
Undergarments ✓ ✓ ✓ ✓ ○ ○ ○
Coats X X X X ○ ✓ ✓
Facemasks ○ ✓ ✓ ✓ ○ ○ ○
Gloves ✓ ✓ ✓ ✓ ○ ○ ○
Bouffant Caps ○ ✓ ✓ ✓ ✓ ✓ ✓

Key: ✓ Recommended    ○ Application Specific    X Not Recommended


Key Takeaways

  • People shed millions of dead skin cells per day and are the greatest risk of Clean Room contamination.
  • The particulate count in the air within an enclosed space gives that room its specific ISO classification from 1 – 9.
  • Sterile medical gloves are not ‘clean’ enough for hospital clean rooms.
  • Follow IEST-RP-CC003.4 for selecting Clean Room apparel.

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