Pharmaceutical Quality Assurance

PHARM-4703 Environmental Monitoring

Environmental monitoring is a check with a view to taking timely corrective measures for
maintaining a favourable manufacturing environment, minimising the risk of product
contamination. It is also a part of validation exercise.

The control limits for environmental monitoring are normally set at three levels which can be
termed as

I) Alert limit,

II) Action limit &

III) Acceptable limit.

The purpose of these three ranges of limits is to avoid unnecessary interruption of production and
allow timely corrective measures which signifies as follows:

 Alert limit: To alert all concerned in advance for due attention and plan for action.
 Action limit: To allow corrective measures without affecting the batches or production.
 Acceptable limit: A limit to continue production, beyond which the manufacturing must
stop for necessary repair, maintenance or other corrective actions.

These limits have to be set as per working experience. Where no margin is allowed, the acceptable
limit naturally remains the only criteria for judging the environment as suitable for continuing
production. For instance at the aseptic filling point the limit of nil microbial count, under the
specified monitoring test, is an absolute limit.

Microscopic examination of the nature of the particles present gives important information on the
source of contaminants allowing necessary corrective measures as needed; for instance

Compiled by: Md. Masud Morshed Page 1

Department of Pharmacy; IIUC
 Pharmaceutical Quality Assurance

PHARM-4703 Environmental Monitoring

Control Limits:

Control limits are established based on the type and quantity of pharmaceuticals being produced,
as well as the environmental sensitivity of the surrounding area. The control limits are used to
determine if environmental conditions are within acceptable limits and to trigger corrective action
if necessary. The control limits are typically established based on regulatory requirements and
industry best practices.

Techniques for Environmental Monitoring: There are several techniques used for
environmental monitoring in the pharmaceutical industry, including:

1. Air Monitoring: Air monitoring is conducted to measure the levels of airborne pharmaceuticals
in and around manufacturing facilities. This can be done using air sampling pumps, passive
samplers, and real-time monitoring equipment.

2. Water Monitoring: Water monitoring is conducted to ensure that wastewater discharged from
pharmaceutical manufacturing facilities meets regulatory requirements. This can be done using
on-site testing equipment, as well as by sending samples to an off-site laboratory for analysis.

3. Soil Monitoring: Soil monitoring is conducted to assess the potential impact of pharmaceuticals
on soil quality. This can be done using soil sampling equipment and laboratory analysis.

4. Surface Monitoring: Surface monitoring is conducted to detect any pharmaceutical residues

that may have accumulated on surfaces in and around manufacturing facilities. This can be done
using swabs, wipes, and other sampling methods.

Environmental Protection and Procedures:

Environmental protection and procedures in the pharmaceutical industry typically involve the
following:

1. Compliance with Regulatory Requirements: Pharmaceutical manufacturers are required to

comply with environmental regulations and guidelines established by regulatory agencies.

2. Waste Management: Proper management of pharmaceutical waste is essential to protect the

environment. This includes the proper handling, storage, and disposal of pharmaceutical waste.

3. Good Manufacturing Practices (GMPs): GMPs are guidelines that ensure the safety, quality,
and efficacy of pharmaceutical products. Adherence to GMPs can help minimize the
environmental impact of pharmaceutical manufacturing.

Compiled by: Md. Masud Morshed Page 2

Department of Pharmacy; IIUC
 Pharmaceutical Quality Assurance

PHARM-4703 Environmental Monitoring

4. Environmental Management Systems (EMS): EMS are comprehensive management systems

that help pharmaceutical manufacturers identify and manage environmental risks. EMS can help
ensure that environmental monitoring and protection measures are integrated into overall business
processes.

A wide range of checks are needed for environmental monitoring. The techniques generally
employed for monitoring are as follows:

Compiled by: Md. Masud Morshed Page 3

Department of Pharmacy; IIUC
 Pharmaceutical Quality Assurance

PHARM-4703 Environmental Monitoring

Settle Plate Technique:

Petridishes containing sterile microbiological growth media in agar are exposed to the
environment. Viable organisms then settle on the exposed media surface and are. subjected to
incubation which will visualise the microbial growth. The settling of organisms is random and
depends on the particle size and the air currents.

Advantages of Settle plate technique: This is a simple portable qualitative technique as well as
inexpensive.

Precaution: The length of plate exposure in the sterile area should be about 1 hour to assess the
air quality. Some manufacturers expose the plate upto 2 hours. A very long exposure, say over 2
hours, may result in drying of the surface of the agar medium and as a result might suppress the
microbial growth. Normally nutrient agar is used but occasionally medium which supports fungal
growth should also be used.

Slit Sampling Technique:

The preparation of the plates is the same as settle plates. But in this case special equipment is
necessary to rotate the plates while through a slit type opening a fixed volume of air is forced on
to the plate. The plate is then incubated.

Advantages:

The method is qualitative as well as quantitative, portable and efficient.

Surface Swabs Technique:

Sterilized swabs of cotton buds are moistened in a sterile diluent or a suitable liquid culture media.
A specific area is then swabbed and the organism sampled from that surface is then smoothly
rubbed over the supporting agar surface (in plates) and incubated. This technique is also
advantageous for irregular surfaces.

Compiled by: Md. Masud Morshed Page 4

Department of Pharmacy; IIUC