II. Scope
This solution is suitable for the formulation chamber clean area to verify the effect of the cleaning and disinfection.
three. Verification team and responsibilities
IV. Content
1 Overview
According to GMP requirements, each should have put into production after cleaning procedures for plant and clean production environment and production area is cleaned or disinfected prior to production, and the use of disinfectants species to be regularly replaced to prevent the generation of drug-resistant strains, is here, the primary authentication scheme verification after cleaning and disinfection required to check the effect of the cleaning and disinfection and by visual method for detecting microorganisms, the cleaning procedures to evaluate the clean area, to prevent contamination and cross-contamination of effectiveness and feasibility.
2. Implementation Frequency
To demonstrate the cleaner production environment clean area D, feasibility and reliability of the sterilization procedure, a certain number of verification required continuously ensure reproducibility, in this authentication scheme, the number is verified three times in succession.
3. verification method
3.1 Selection of cleaning agents and disinfectants
Cleaning agent: 1% NaHCO3 solution, purified water, water for injection
Disinfectants: 5% cresol soap solution, 0.1% benzalkonium bromide solution, 75% ethanol.
3.2 sampling operation
3.3.1 Buildings and facilities cleaning effect check:
After completion of the cleaning plant according to the cleaning procedure, the respective portions visually, production areas facilities, equipment and manufacturing surface without visible foreign matter remnants after no stains mercerized clean towel. 3.3.2 disinfection plant facilities check: 3.3.2.3 Determination of surface microbial count
1, the tab 20 cotton, forceps into a container box, the box with moist heat sterilization at 121 deg.] C, 20min after heat sterilization, out, cooled standby.
2, absorbent cotton wetted with sterile saline check sterilized tweezers and a cotton swab to take their pressing against the solvent vial to remove excess solvent.
3, the forceps with a sterilized swab head according to the sampling surface, slightly curved so hard, smooth and slow sampling wiping surface. While moving forward to move it from side to side. It should cover the entire surface of the wiping process. Flip swab, let the other side is also a cotton swab to wipe. However, the wiping movement direction perpendicular to the previous.
FIG :( below the wiping area of about 25cm2)
Sampling swab schematic
4, after the wiping is completed, the check cotton wipe test tube end, and sealed with a screw cap screwed. After the sampling is done on a test tube marked sampling information.
5, the blank prepared in reference do, step 2 by wet swab, the swab tip into the tube, and sealed with a screw cap screwed. After the sampling is done on a test tube marked sampling information.
6, the swab placed in 5ml sterile saline, microbial limit test ultrasonically washed for 2 minutes, washed with water taken, the agar was poured into petri dishes, to take a cotton swab was washed in water, 1ml per dish uniformly coated on the culture medium, culturing 30-35 ℃ 48 hours to observe the number of colonies, the total number of colonies per dish summed. Calculating the average number of colonies (results shown in Table 5).
7, sampling frequency: Each room is carried out three consecutive validation. Each time after the first day of each cleaning plant, the third day, fifth day and seventh day of sampling points at the same position.
8, the sample points: the gate process, respectively (total surface point) in each room, the wall (at the corner of the wall to the ground and two n-CCP), the roof (the roof and wall corner and two roof CCP point), floor (entrance, ground two positive CCP), the table (surface). Each point of the wiping area of 25cm2. Clean room (area) sampling points are arranged to be uniform to avoid too sparse sampling point in a local area. Sampling room and sampling points are as follows:
Only clean area detection surface of the device, among other surfaces (floors, walls, door handle) sampling.
4. Verifiable Indicators
4.1 for each part of the visual inspection, production areas facilities, equipment and manufacturing surface without visible foreign matter remnants after no stains mercerized clean towel.
4.2 swab wash water for microbiological examination, the number of colonies was observed, the total number of colonies per dish is calculated by adding the average number of colonies. Range of microorganisms on the surface of the facility shall not exceed the number of colonies in the table below.
5. Verify embodiment
All validation experiments to be in a table (table inspection records system elements) are in the situation must meet the following requirements. Based on "clean area cleaning tools cleaning and disinfection procedure" (SOP / SCQ005-2013 (Rev.3), to carry out cleaning and disinfection plant, sampling detection (detection results see table) in accordance with the sampling method.
6. Evaluation of the verification result and
Assessment procedures according to the results of verification "Authentication Management Regulations" (SMP / QAT006-2013 (Rev.5)) execution.
7. Verify Cycle
According verification team responsible for cleaning, disinfection D grade production areas, the development of revalidation cycle, verify the reported overall responsibility for approval.
V. deviation handling
In the process of verifying the implementation of the program in program implementation should ensure correct operation, the deviation should be documented occur due to an authentication method, and propose appropriate solutions. Verification team leader responsible for overseeing the implementation of the whole process.
VI. Accessories
Schedule Check a cleaning effect
Table II records microbial detection
