It is no secret that numerous outbreaks in the past could be traced right back to the plant where the contamination started. This is why practicing and validating good cleaning according to GMP Cleaning Procedures is of utmost importance.
To ensure good clean procedures, GMP advises on the following steps to ensure that your facility fulfills a quality validation process.
4 Key GMP Cleaning Procedures
Disassembly and Isolation
Depending on the part that you need to be clean, you would have to either do a complete strip or take the equipment apart to some extent for cleaning. For the best cleaning results, isolate the equipment or the required parts and then clean it entirely.
You cannot validate the cleaning procedure if you only clean a portion of the isolated part. For cleaning, you would generally use a liquid detergent and rinse the part with deionized water.
Drying
This step is not compulsory. Drying depends on the urgency for the use of the equipment following the cleaning. If you need to use the equipment within a few hours then a proper drying process is vital.
Drying is important because water left behind may result in microbial growth. The drying method includes heating and a final rinse with alcohol or a water rinse.
Reassembly and storage
The next step is to reassemble the parts that you disassembled for cleaning.
When storing these parts before reassembling them, make sure that you protect them against recontamination by setting a storage expiration date.
This will help prevent the following from happening:
- The equipment becoming critically dry.
- Recontamination if stored wrapped in plastic.
- Thick dust and moisture if the storage room is not adequate.
So before the storage time expires, make sure you specify the reuse date to avoid performance issues.
Automated CIP systems
CIP is a mechanical system where you place one or more spray devices in the equipment that needs cleaning. Automated CIP systems automatically clean the parts with no or minimal equipment takedown.
The device has a control unit that includes a pump that is linked with valves. It pumps the cleaning liquid from the storage tank through the spray devices.
There are two types of CIP systems:
- The non-circulating system is where the cleaning solution passes once through the vessels and then drains.
- A circulating system is when the cleaning solution passes through the vessels numerous times via a recycling system.
Cleaning Validation
It is a standard GMP practice to record and document your facility’s cleaning procedures and validate them to ensure they work effectively.
It is important to follow GMP cleaning procedures under valid conditions in order to comply with GMP requirements.
If you don’t follow cleaning procedures under the correct conditions, your cleaning process will be invalidated.
Cleaning Conditions
You need to follow written cleaning procedures so that you can conduct your cleaning in the best way possible.
The process may include a few of the following conditions:
- How much to disassemble equipment before you start cleaning
- The pH of the cleaning solution you use
- The type of water or solvent you will use for cleaning
- The temperature of the water
- The strength of the cleaning or sanitizing agent
- What you will use to clean off the sanitizing agent
- The type of water you use to rinse your equipment
Records
It’s crucial to keep detailed cleaning records and store them in a safe place. This is so that you can refer back to them when necessary. They prove that you have followed correct GMP cleaning procedures.
The documentation of cleaning needs to provide all relevant information like the date, result, and conditions. It also needs to disclose the name of the person who did the cleaning as well as their signature.
Automated procedures are usually observed automatically and the circumstances are recorded. In general, CIP systems also have alarms installed so that they can alert someone when something goes wrong during cleaning. This helps to keep track of cleaning conditions and correct any errors.
Conclusion
GMP cleaning procedures are stringent in order to prevent any type of contamination from occurring. It is crucial that Pharmaceuticals and Manufacturing facilities have written cleaning practices in place to ensure effective cleaning takes place.